Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT01285518
Status:
COMPLETED
Last Update Posted:
2016-11-18
First Post:
2011-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000604284', 'term': 'PF-05231023'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Results for C0 and Vss was included as secondary endpoints as per change in the planned analysis.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 2, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 10, 'otherNumAffected': 8, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.', 'otherNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hyperchlorhydria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Administration site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Early satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Ecchymosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 10, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 10, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 14, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Physical Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'timeFrame': 'Day -1 up to Day 22', 'description': "Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned.", 'reportingStatus': 'POSTED', 'populationDescription': "Data was not collected since this outcome measure was not analyzed as per Sponsor's discretion."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '5', 'groupId': 'OG007'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 22', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day -1 up to Day 15', 'description': 'Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than \\[\\<\\] 0.8\\*lower limit of normal\\[LLN\\]); leucocytes (\\<0.6/greater than \\[\\>\\]1.5\\*upper limit of normal \\[ULN\\]); platelets (\\<0.5\\*LLN/\\>1.75\\*ULN); neutrophils, lymphocytes (\\<0.8\\*LLN/\\>1.2\\*ULN); eosinophils, basophils, monocytes (\\>1.2\\*ULN); total bilirubin, direct bilirubin, indirect bilirubin (\\>1.5\\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (\\>3\\*ULN), total protein, albumin (\\<0.8\\*LLN/\\>1.2\\*ULN); creatinine, urea (\\>1.3\\*ULN); glucose (\\<0.6\\*LLN/\\>1.5\\*ULN); uric acid (\\>1.2\\*ULN); sodium, potassium, chloride, calcium, bicarbonate (\\<0.9\\*LLN/\\>1.1\\*ULN); urine RBCs, urine white blood cells (WBCs) (\\> or equal\\[=\\]20 high-powered field), urine bacteria \\>20 high-powered field. Total number of participants with any laboratory abnormalities was reported.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Vital Signs Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'Supine SBP <90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Supine DBP <50 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine pulse rate <40 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine pulse rate >120 bpm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Supine SBP: Maximum increase >=30 mmHg', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine DBP: Maximum increase >=20 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Supine SBP: Maximum decrease >=30 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Supine DBP: Maximum decrease >=20 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 15', 'description': 'Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) \\<90 millimeter of mercury (mmHg), supine diastolic BP (DBP) \\<50 mmHg, supine pulse rate \\<40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP \\>=30 mmHg and maximum increase or decrease from baseline in supine DBP \\>=20 mmHg.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'Maximum PR interval >=300 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Maximum QRS Complex >=140 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Maximum QTCF interval 450 to <480 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Maximum QTCF interval 480 to <500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Maximum QTCF interval >=500 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'PR interval increase from baseline >=25/50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QRS complex increase from baseline >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QTCF interval increase from baseline 30 to 60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'QTCF interval increase from baseline >=60 msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Screening up to Day 15', 'description': "Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (\\>=) 300 milliseconds (msec), maximum QRS interval \\>=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to \\<480 msec, 480 to \\<500 msec and \\>=500 msec, maximum increase of \\>=25 percent (%) for baseline value of \\>200 msec for PR interval and maximum increase of \\>=50% for baseline value of less than or equal to (\\<=) 200 msec for QRS interval, maximum increase from baseline of \\>=30 msec to \\<60 msec and maximum increase from baseline of \\>60 msec in QTCF interval (Fridericia's Correction).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'Severe Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Documented Symptomatic Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Asymptomatic Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}]}, {'title': 'Probable Symptomatic Hypoglycemia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 up to Day 22', 'description': 'Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose \\<50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration \\<=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration \\<=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration \\<=70 mg/dL).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Blood Glucose Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': '<0.6*LLN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': '>1.5*ULN', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '9', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day -1 up to Day 15', 'description': 'Criteria for blood glucose abnormality: Blood glucose levels \\<0.6\\*lower limit of normal (LLN) or \\>1.5\\*upper limit of normal (ULN).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 8', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 15', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study medication. No participant in the placebo group was assessed for this time point of outcome measure, hence results were not reported for the same. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 22', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all participants who received at least 1 dose of study medication. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 34', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 34', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population. No participant was involved in groups: PF-05231023 0.5,1.5,5,15,50,100 mg and placebo for this time point of outcome measure, hence results were not reported for the same.'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1', 'categories': [{'measurements': [{'value': '137.2', 'spread': '69.33', 'groupId': 'OG000'}, {'value': '142.3', 'spread': '47.10', 'groupId': 'OG001'}, {'value': '143.4', 'spread': '42.80', 'groupId': 'OG002'}, {'value': '146.8', 'spread': '50.97', 'groupId': 'OG003'}, {'value': '128.4', 'spread': '35.44', 'groupId': 'OG004'}, {'value': '135.7', 'spread': '59.12', 'groupId': 'OG005'}, {'value': '153.1', 'spread': '51.57', 'groupId': 'OG006'}, {'value': '131.3', 'spread': '34.71', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1', 'categories': [{'measurements': [{'value': '1.83', 'spread': '1.414', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '0.525', 'groupId': 'OG001'}, {'value': '2.63', 'spread': '2.954', 'groupId': 'OG002'}, {'value': '2.81', 'spread': '2.454', 'groupId': 'OG003'}, {'value': '1.20', 'spread': '0.995', 'groupId': 'OG004'}, {'value': '2.23', 'spread': '3.138', 'groupId': 'OG005'}, {'value': '2.88', 'spread': '1.724', 'groupId': 'OG006'}, {'value': '1.69', 'spread': '1.292', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2', 'categories': [{'measurements': [{'value': '173.5', 'spread': '109.33', 'groupId': 'OG000'}, {'value': '134.2', 'spread': '50.00', 'groupId': 'OG001'}, {'value': '143.8', 'spread': '48.44', 'groupId': 'OG002'}, {'value': '197.1', 'spread': '147.01', 'groupId': 'OG003'}, {'value': '108.8', 'spread': '39.77', 'groupId': 'OG004'}, {'value': '147.9', 'spread': '89.58', 'groupId': 'OG005'}, {'value': '204.7', 'spread': '122.70', 'groupId': 'OG006'}, {'value': '146.7', 'spread': '79.50', 'groupId': 'OG007'}]}]}, {'title': 'GH', 'categories': [{'measurements': [{'value': '0.178', 'spread': '0.2981', 'groupId': 'OG000'}, {'value': '0.121', 'spread': '0.1521', 'groupId': 'OG001'}, {'value': '0.133', 'spread': '0.1629', 'groupId': 'OG002'}, {'value': '0.222', 'spread': '0.2189', 'groupId': 'OG003'}, {'value': '0.316', 'spread': '0.4162', 'groupId': 'OG004'}, {'value': '0.296', 'spread': '0.5557', 'groupId': 'OG005'}, {'value': '0.448', 'spread': '0.5928', 'groupId': 'OG006'}, {'value': '0.079', 'spread': '0.0355', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1', 'categories': [{'measurements': [{'value': '141.1', 'spread': '75.35', 'groupId': 'OG000'}, {'value': '148.0', 'spread': '47.00', 'groupId': 'OG001'}, {'value': '163.5', 'spread': '50.79', 'groupId': 'OG002'}, {'value': '152.9', 'spread': '51.08', 'groupId': 'OG003'}, {'value': '145.0', 'spread': '63.28', 'groupId': 'OG004'}, {'value': '154.9', 'spread': '55.30', 'groupId': 'OG005'}, {'value': '168.4', 'spread': '58.24', 'groupId': 'OG006'}, {'value': '135.7', 'spread': '33.89', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1', 'categories': [{'measurements': [{'value': '2.72', 'spread': '2.068', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '1.570', 'groupId': 'OG001'}, {'value': '2.37', 'spread': '2.489', 'groupId': 'OG002'}, {'value': '4.37', 'spread': '4.093', 'groupId': 'OG003'}, {'value': '2.67', 'spread': '1.830', 'groupId': 'OG004'}, {'value': '2.41', 'spread': '1.711', 'groupId': 'OG005'}, {'value': '4.49', 'spread': '2.824', 'groupId': 'OG006'}, {'value': '3.01', 'spread': '2.954', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2', 'categories': [{'measurements': [{'value': '153.1', 'spread': '80.23', 'groupId': 'OG000'}, {'value': '130.2', 'spread': '43.42', 'groupId': 'OG001'}, {'value': '154.4', 'spread': '47.72', 'groupId': 'OG002'}, {'value': '200.7', 'spread': '171.17', 'groupId': 'OG003'}, {'value': '117.7', 'spread': '41.88', 'groupId': 'OG004'}, {'value': '174.1', 'spread': '104.64', 'groupId': 'OG005'}, {'value': '212.6', 'spread': '137.72', 'groupId': 'OG006'}, {'value': '160.1', 'spread': '87.53', 'groupId': 'OG007'}]}]}, {'title': 'GH', 'categories': [{'measurements': [{'value': '0.230', 'spread': '0.3135', 'groupId': 'OG000'}, {'value': '0.369', 'spread': '0.7146', 'groupId': 'OG001'}, {'value': '0.182', 'spread': '0.2109', 'groupId': 'OG002'}, {'value': '0.386', 'spread': '0.3823', 'groupId': 'OG003'}, {'value': '0.316', 'spread': '0.3116', 'groupId': 'OG004'}, {'value': '0.407', 'spread': '0.4363', 'groupId': 'OG005'}, {'value': '0.620', 'spread': '0.4641', 'groupId': 'OG006'}, {'value': '0.498', 'spread': '0.8284', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1', 'categories': [{'measurements': [{'value': '140.1', 'spread': '62.82', 'groupId': 'OG000'}, {'value': '147.5', 'spread': '45.10', 'groupId': 'OG001'}, {'value': '158.6', 'spread': '46.26', 'groupId': 'OG002'}, {'value': '164.2', 'spread': '57.90', 'groupId': 'OG003'}, {'value': '156.3', 'spread': '75.73', 'groupId': 'OG004'}, {'value': '149.8', 'spread': '57.41', 'groupId': 'OG005'}, {'value': '178.5', 'spread': '53.85', 'groupId': 'OG006'}, {'value': '137.7', 'spread': '33.10', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1', 'categories': [{'measurements': [{'value': '2.30', 'spread': '1.910', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.947', 'groupId': 'OG001'}, {'value': '2.38', 'spread': '2.863', 'groupId': 'OG002'}, {'value': '3.00', 'spread': '2.682', 'groupId': 'OG003'}, {'value': '4.27', 'spread': '4.803', 'groupId': 'OG004'}, {'value': '2.70', 'spread': '3.519', 'groupId': 'OG005'}, {'value': '3.10', 'spread': '1.694', 'groupId': 'OG006'}, {'value': '2.00', 'spread': '1.393', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2', 'categories': [{'measurements': [{'value': '160.4', 'spread': '106.14', 'groupId': 'OG000'}, {'value': '135.7', 'spread': '47.46', 'groupId': 'OG001'}, {'value': '144.4', 'spread': '43.00', 'groupId': 'OG002'}, {'value': '188.2', 'spread': '138.45', 'groupId': 'OG003'}, {'value': '129.1', 'spread': '42.61', 'groupId': 'OG004'}, {'value': '155.0', 'spread': '99.66', 'groupId': 'OG005'}, {'value': '223.3', 'spread': '120.05', 'groupId': 'OG006'}, {'value': '145.2', 'spread': '61.69', 'groupId': 'OG007'}]}]}, {'title': 'GH', 'categories': [{'measurements': [{'value': '0.186', 'spread': '0.2030', 'groupId': 'OG000'}, {'value': '0.192', 'spread': '0.1165', 'groupId': 'OG001'}, {'value': '0.273', 'spread': '0.3549', 'groupId': 'OG002'}, {'value': '0.312', 'spread': '0.3008', 'groupId': 'OG003'}, {'value': '0.432', 'spread': '0.6493', 'groupId': 'OG004'}, {'value': '0.406', 'spread': '0.3544', 'groupId': 'OG005'}, {'value': '0.588', 'spread': '0.4084', 'groupId': 'OG006'}, {'value': '0.169', 'spread': '0.1647', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.', 'unitOfMeasure': 'nanogram per millileter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1', 'categories': [{'measurements': [{'value': '138.4', 'spread': '74.86', 'groupId': 'OG000'}, {'value': '156.1', 'spread': '40.03', 'groupId': 'OG001'}, {'value': '152.7', 'spread': '48.18', 'groupId': 'OG002'}, {'value': '155.4', 'spread': '54.29', 'groupId': 'OG003'}, {'value': '136.9', 'spread': '54.82', 'groupId': 'OG004'}, {'value': '143.6', 'spread': '54.03', 'groupId': 'OG005'}, {'value': '163.6', 'spread': '44.96', 'groupId': 'OG006'}, {'value': '137.0', 'spread': '27.00', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1', 'categories': [{'measurements': [{'value': '2.45', 'spread': '2.186', 'groupId': 'OG000'}, {'value': '2.36', 'spread': '1.629', 'groupId': 'OG001'}, {'value': '2.61', 'spread': '2.497', 'groupId': 'OG002'}, {'value': '2.93', 'spread': '2.547', 'groupId': 'OG003'}, {'value': '4.02', 'spread': '4.484', 'groupId': 'OG004'}, {'value': '2.64', 'spread': '3.102', 'groupId': 'OG005'}, {'value': '3.11', 'spread': '1.805', 'groupId': 'OG006'}, {'value': '2.31', 'spread': '2.466', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2', 'categories': [{'measurements': [{'value': '169.1', 'spread': '101.02', 'groupId': 'OG000'}, {'value': '129.4', 'spread': '44.14', 'groupId': 'OG001'}, {'value': '152.4', 'spread': '61.19', 'groupId': 'OG002'}, {'value': '193.1', 'spread': '137.11', 'groupId': 'OG003'}, {'value': '135.5', 'spread': '43.32', 'groupId': 'OG004'}, {'value': '156.1', 'spread': '117.61', 'groupId': 'OG005'}, {'value': '207.9', 'spread': '97.73', 'groupId': 'OG006'}, {'value': '150.1', 'spread': '69.66', 'groupId': 'OG007'}]}]}, {'title': 'GH', 'categories': [{'measurements': [{'value': '0.190', 'spread': '0.2492', 'groupId': 'OG000'}, {'value': '0.146', 'spread': '0.0802', 'groupId': 'OG001'}, {'value': '0.169', 'spread': '0.1788', 'groupId': 'OG002'}, {'value': '0.233', 'spread': '0.1884', 'groupId': 'OG003'}, {'value': '0.271', 'spread': '0.3159', 'groupId': 'OG004'}, {'value': '0.188', 'spread': '0.1641', 'groupId': 'OG005'}, {'value': '0.484', 'spread': '0.4962', 'groupId': 'OG006'}, {'value': '0.216', 'spread': '0.2418', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.', 'unitOfMeasure': 'nanogram per millileter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1 (n=10,10,10,10,10,10,10,14)', 'categories': [{'measurements': [{'value': '142.1', 'spread': '73.55', 'groupId': 'OG000'}, {'value': '151.0', 'spread': '47.72', 'groupId': 'OG001'}, {'value': '152.3', 'spread': '54.13', 'groupId': 'OG002'}, {'value': '157.1', 'spread': '61.32', 'groupId': 'OG003'}, {'value': '130.4', 'spread': '55.44', 'groupId': 'OG004'}, {'value': '143.9', 'spread': '59.06', 'groupId': 'OG005'}, {'value': '154.1', 'spread': '41.88', 'groupId': 'OG006'}, {'value': '132.5', 'spread': '28.07', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1 (n=10,10,10,10,10,9,10,14)', 'categories': [{'measurements': [{'value': '4.67', 'spread': '3.533', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '2.113', 'groupId': 'OG001'}, {'value': '3.03', 'spread': '3.261', 'groupId': 'OG002'}, {'value': '2.98', 'spread': '3.948', 'groupId': 'OG003'}, {'value': '2.61', 'spread': '2.348', 'groupId': 'OG004'}, {'value': '2.80', 'spread': '3.440', 'groupId': 'OG005'}, {'value': '3.39', 'spread': '1.824', 'groupId': 'OG006'}, {'value': '3.46', 'spread': '4.404', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2 (n=10,10,10,10,10,9,10,14)', 'categories': [{'measurements': [{'value': '187.7', 'spread': '107.34', 'groupId': 'OG000'}, {'value': '116.5', 'spread': '30.62', 'groupId': 'OG001'}, {'value': '166.4', 'spread': '48.32', 'groupId': 'OG002'}, {'value': '178.7', 'spread': '126.83', 'groupId': 'OG003'}, {'value': '132.8', 'spread': '46.18', 'groupId': 'OG004'}, {'value': '173.8', 'spread': '148.78', 'groupId': 'OG005'}, {'value': '229.8', 'spread': '118.94', 'groupId': 'OG006'}, {'value': '154.7', 'spread': '88.03', 'groupId': 'OG007'}]}]}, {'title': 'GH (n=10,10,10,10,10,10,10,14)', 'categories': [{'measurements': [{'value': '0.233', 'spread': '0.2506', 'groupId': 'OG000'}, {'value': '0.112', 'spread': '0.0738', 'groupId': 'OG001'}, {'value': '0.108', 'spread': '0.0760', 'groupId': 'OG002'}, {'value': '0.254', 'spread': '0.3971', 'groupId': 'OG003'}, {'value': '0.142', 'spread': '0.1003', 'groupId': 'OG004'}, {'value': '0.120', 'spread': '0.1067', 'groupId': 'OG005'}, {'value': '0.320', 'spread': '0.1942', 'groupId': 'OG006'}, {'value': '0.201', 'spread': '0.2193', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. Here,'n' signifies participants who were evaluable at each specified time point for each arm, respectively."}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'IGF-1 (n=10,10,9,10,10,9,9,14)', 'categories': [{'measurements': [{'value': '117.7', 'spread': '55.26', 'groupId': 'OG000'}, {'value': '132.6', 'spread': '42.72', 'groupId': 'OG001'}, {'value': '116.7', 'spread': '38.99', 'groupId': 'OG002'}, {'value': '131.2', 'spread': '45.53', 'groupId': 'OG003'}, {'value': '106.2', 'spread': '44.50', 'groupId': 'OG004'}, {'value': '123.2', 'spread': '51.08', 'groupId': 'OG005'}, {'value': '126.3', 'spread': '40.32', 'groupId': 'OG006'}, {'value': '112.5', 'spread': '25.85', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-1 (n=10,10,9,10,10,9,9,14)', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.999', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '1.573', 'groupId': 'OG001'}, {'value': '2.90', 'spread': '3.357', 'groupId': 'OG002'}, {'value': '2.28', 'spread': '2.262', 'groupId': 'OG003'}, {'value': '2.70', 'spread': '2.186', 'groupId': 'OG004'}, {'value': '3.23', 'spread': '3.567', 'groupId': 'OG005'}, {'value': '3.36', 'spread': '2.261', 'groupId': 'OG006'}, {'value': '2.11', 'spread': '1.690', 'groupId': 'OG007'}]}]}, {'title': 'IGFBP-2 (n=10,10,9,10,10,9,9,14)', 'categories': [{'measurements': [{'value': '215.6', 'spread': '89.55', 'groupId': 'OG000'}, {'value': '154.7', 'spread': '38.39', 'groupId': 'OG001'}, {'value': '157.3', 'spread': '60.35', 'groupId': 'OG002'}, {'value': '240.8', 'spread': '177.76', 'groupId': 'OG003'}, {'value': '155.4', 'spread': '49.16', 'groupId': 'OG004'}, {'value': '193.1', 'spread': '145.98', 'groupId': 'OG005'}, {'value': '247.3', 'spread': '145.61', 'groupId': 'OG006'}, {'value': '181.6', 'spread': '129.74', 'groupId': 'OG007'}]}]}, {'title': 'GH (n=10,10,9,10,10,9,9,14)', 'categories': [{'measurements': [{'value': '0.216', 'spread': '0.2557', 'groupId': 'OG000'}, {'value': '0.135', 'spread': '0.1039', 'groupId': 'OG001'}, {'value': '0.133', 'spread': '0.1111', 'groupId': 'OG002'}, {'value': '0.115', 'spread': '0.0920', 'groupId': 'OG003'}, {'value': '0.090', 'spread': '0.0927', 'groupId': 'OG004'}, {'value': '0.161', 'spread': '0.1388', 'groupId': 'OG005'}, {'value': '0.183', 'spread': '0.2236', 'groupId': 'OG006'}, {'value': '0.180', 'spread': '0.1628', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. 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'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '12', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.09', 'spread': '1.028', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '1.325', 'groupId': 'OG001'}, {'value': '3.80', 'spread': '1.026', 'groupId': 'OG002'}, {'value': '3.47', 'spread': '0.804', 'groupId': 'OG003'}, {'value': '3.52', 'spread': '1.260', 'groupId': 'OG004'}, {'value': '3.44', 'spread': '1.198', 'groupId': 'OG005'}, {'value': '3.52', 'spread': '1.003', 'groupId': 'OG006'}, {'value': '3.66', 'spread': '0.925', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'microgram per milliliter (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.11', 'spread': '0.983', 'groupId': 'OG000'}, {'value': '4.04', 'spread': '1.211', 'groupId': 'OG001'}, {'value': '3.78', 'spread': '0.887', 'groupId': 'OG002'}, {'value': '3.49', 'spread': '0.839', 'groupId': 'OG003'}, {'value': '3.79', 'spread': '1.440', 'groupId': 'OG004'}, {'value': '3.53', 'spread': '1.069', 'groupId': 'OG005'}, {'value': '3.53', 'spread': '0.888', 'groupId': 'OG006'}, {'value': '3.63', 'spread': '0.986', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 2', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.14', 'spread': '0.964', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '1.180', 'groupId': 'OG001'}, {'value': '3.82', 'spread': '0.957', 'groupId': 'OG002'}, {'value': '3.56', 'spread': '0.957', 'groupId': 'OG003'}, {'value': '3.69', 'spread': '1.433', 'groupId': 'OG004'}, {'value': '3.38', 'spread': '0.907', 'groupId': 'OG005'}, {'value': '3.54', 'spread': '0.948', 'groupId': 'OG006'}, {'value': '3.75', 'spread': '0.924', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous 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'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.12', 'spread': '0.930', 'groupId': 'OG000'}, {'value': '3.98', 'spread': '1.269', 'groupId': 'OG001'}, {'value': '3.89', 'spread': '1.026', 'groupId': 'OG002'}, {'value': '3.53', 'spread': '0.830', 'groupId': 'OG003'}, {'value': '3.41', 'spread': '1.242', 'groupId': 'OG004'}, {'value': '3.27', 'spread': '1.024', 'groupId': 'OG005'}, {'value': '3.32', 'spread': '0.747', 'groupId': 'OG006'}, {'value': '3.60', 'spread': '0.969', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with 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'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.27', 'spread': '1.049', 'groupId': 'OG000'}, {'value': '4.01', 'spread': '1.297', 'groupId': 'OG001'}, {'value': '3.84', 'spread': '0.969', 'groupId': 'OG002'}, {'value': '3.58', 'spread': '0.968', 'groupId': 'OG003'}, {'value': '3.43', 'spread': '1.378', 'groupId': 'OG004'}, {'value': '3.25', 'spread': '0.996', 'groupId': 'OG005'}, {'value': '3.32', 'spread': '0.721', 'groupId': 'OG006'}, {'value': '3.51', 'spread': '0.901', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 7', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint.'}, {'type': 'PRIMARY', 'title': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}, {'value': '9', 'groupId': 'OG006'}, {'value': '14', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.88', 'spread': '0.884', 'groupId': 'OG000'}, {'value': '3.72', 'spread': '1.166', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '0.961', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '0.654', 'groupId': 'OG003'}, {'value': '3.11', 'spread': '1.135', 'groupId': 'OG004'}, {'value': '3.30', 'spread': '0.890', 'groupId': 'OG005'}, {'value': '3.20', 'spread': '0.876', 'groupId': 'OG006'}, {'value': '3.46', 'spread': '0.920', 'groupId': 'OG007'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 15', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Pharmacodynamic analysis set included all participants treated with PF-05231023 or placebo who had at least 1 pharmacodynamic endpoint. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'timeFrame': 'From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1', 'description': "Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned.", 'reportingStatus': 'POSTED', 'populationDescription': "Data was not collected since this outcome measure was not analyzed as per Sponsor's discretion."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal', 'categories': [{'measurements': [{'value': '672.3', 'spread': '364.50', 'groupId': 'OG000'}, {'value': '2573', 'spread': '475.73', 'groupId': 'OG001'}, {'value': '10220', 'spread': '4059.2', 'groupId': 'OG002'}, {'value': '29390', 'spread': '6697.4', 'groupId': 'OG003'}, {'value': '95120', 'spread': '13749', 'groupId': 'OG004'}, {'value': '244200', 'spread': '83895', 'groupId': 'OG005'}, {'value': '409300', 'spread': '135030', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal', 'categories': [{'measurements': [{'value': '2957', 'spread': '1887.2', 'groupId': 'OG000'}, {'value': '11630', 'spread': '4363.6', 'groupId': 'OG001'}, {'value': '47650', 'spread': '10833', 'groupId': 'OG002'}, {'value': '168600', 'spread': '50175', 'groupId': 'OG003'}, {'value': '564600', 'spread': '161560', 'groupId': 'OG004'}, {'value': '121100', 'spread': '386970', 'groupId': 'OG005'}, {'value': '280000', 'spread': '756220', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).\n\nParticipants who received PF-05231023 with C-terminal and N-terminal AUClast were reported.', 'unitOfMeasure': 'ng*hour[H]/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal', 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.250', 'upperLimit': '0.533'}, {'value': '0.250', 'groupId': 'OG001', 'lowerLimit': '0.250', 'upperLimit': '0.500'}, {'value': '1.50', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '3.00'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '2.53'}, {'value': '1.26', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.50', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.02', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '2.50'}]}]}, {'title': 'N-terminal', 'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.250', 'upperLimit': '3.03'}, {'value': '0.250', 'groupId': 'OG001', 'lowerLimit': '0.250', 'upperLimit': '1.00'}, {'value': '1.50', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '6.00'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.02', 'upperLimit': '2.50'}, {'value': '1.26', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '1.50', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '2.50'}, {'value': '1.50', 'groupId': 'OG006', 'lowerLimit': '1.00', 'upperLimit': '2.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal', 'categories': [{'measurements': [{'value': '110.7', 'spread': '40.994', 'groupId': 'OG000'}, {'value': '347.9', 'spread': '61.165', 'groupId': 'OG001'}, {'value': '1360', 'spread': '1264.9', 'groupId': 'OG002'}, {'value': '3324', 'spread': '656.74', 'groupId': 'OG003'}, {'value': '11730', 'spread': '4857.6', 'groupId': 'OG004'}, {'value': '28740', 'spread': '8031.1', 'groupId': 'OG005'}, {'value': '47780', 'spread': '13784', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal', 'categories': [{'measurements': [{'value': '121.0', 'spread': '44.923', 'groupId': 'OG000'}, {'value': '393.2', 'spread': '75.603', 'groupId': 'OG001'}, {'value': '1199', 'spread': '386.56', 'groupId': 'OG002'}, {'value': '3693', 'spread': '714.42', 'groupId': 'OG003'}, {'value': '14180', 'spread': '3928.7', 'groupId': 'OG004'}, {'value': '28850', 'spread': '6375.5', 'groupId': 'OG005'}, {'value': '61910', 'spread': '8125.5', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest.'}, {'type': 'SECONDARY', 'title': 'Plasma Terminal Half-Life (t1/2) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal (n=2,10,10,9,10,10,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since less than 3 participants were evaluable.', 'groupId': 'OG000'}, {'value': '6.504', 'spread': '1.0814', 'groupId': 'OG001'}, {'value': '7.168', 'spread': '1.2433', 'groupId': 'OG002'}, {'value': '7.143', 'spread': '1.5009', 'groupId': 'OG003'}, {'value': '7.748', 'spread': '1.1304', 'groupId': 'OG004'}, {'value': '7.502', 'spread': '0.9999', 'groupId': 'OG005'}, {'value': '7.302', 'spread': '1.7117', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal (n=7,9,10,10,9,10,10)', 'categories': [{'measurements': [{'value': '31.49', 'spread': '6.5685', 'groupId': 'OG000'}, {'value': '37.64', 'spread': '9.0438', 'groupId': 'OG001'}, {'value': '66.54', 'spread': '12.792', 'groupId': 'OG002'}, {'value': '77.39', 'spread': '11.979', 'groupId': 'OG003'}, {'value': '81.52', 'spread': '12.599', 'groupId': 'OG004'}, {'value': '87.69', 'spread': '16.556', 'groupId': 'OG005'}, {'value': '96.64', 'spread': '8.0925', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal (n=2,10,10,9,10,10,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since less than 3 participants were evaluable.', 'groupId': 'OG000'}, {'value': '0.5368', 'spread': '0.0972', 'groupId': 'OG001'}, {'value': '0.4642', 'spread': '0.15736', 'groupId': 'OG002'}, {'value': '0.4974', 'spread': '0.12295', 'groupId': 'OG003'}, {'value': '0.5245', 'spread': '0.0892', 'groupId': 'OG004'}, {'value': '0.4092', 'spread': '0.12015', 'groupId': 'OG005'}, {'value': '0.4883', 'spread': '0.25652', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal (n=7,9,10,10,9,10,10)', 'categories': [{'measurements': [{'value': '0.1057', 'spread': '0.0459', 'groupId': 'OG000'}, {'value': '0.1282', 'spread': '0.0417', 'groupId': 'OG001'}, {'value': '0.1014', 'spread': '0.0203', 'groupId': 'OG002'}, {'value': '0.0879', 'spread': '0.03216', 'groupId': 'OG003'}, {'value': '0.08611', 'spread': '0.02916', 'groupId': 'OG004'}, {'value': '0.08050', 'spread': '0.0256', 'groupId': 'OG005'}, {'value': '0.07021', 'spread': '0.0186', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution (Vz) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal (n=2,10,10,9,10,10,10 )', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since less than 3 participants were evaluable.', 'groupId': 'OG000'}, {'value': '4.977', 'spread': '0.93206', 'groupId': 'OG001'}, {'value': '4.741', 'spread': '1.1834', 'groupId': 'OG002'}, {'value': '5.029', 'spread': '0.81502', 'groupId': 'OG003'}, {'value': '5.799', 'spread': '1.5559', 'groupId': 'OG004'}, {'value': '4.397', 'spread': '1.1511', 'groupId': 'OG005'}, {'value': '5.014', 'spread': '1.2498', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal (n=7,9,10,10,9,10,10)', 'categories': [{'measurements': [{'value': '4.709', 'spread': '0.82966', 'groupId': 'OG000'}, {'value': '6.758', 'spread': '1.1934', 'groupId': 'OG001'}, {'value': '9.526', 'spread': '2.2753', 'groupId': 'OG002'}, {'value': '9.704', 'spread': '2.1259', 'groupId': 'OG003'}, {'value': '10.01', 'spread': '2.9519', 'groupId': 'OG004'}, {'value': '9.979', 'spread': '2.7792', 'groupId': 'OG005'}, {'value': '9.767', 'spread': '2.5208', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.', 'unitOfMeasure': 'Liter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all participants randomized and treated who had at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal (n=2,10,10,9,10,10,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since less than 3 participants were evaluable.', 'groupId': 'OG000'}, {'value': '2793', 'spread': '557.86', 'groupId': 'OG001'}, {'value': '10770', 'spread': '3999.8', 'groupId': 'OG002'}, {'value': '30140', 'spread': '7079.3', 'groupId': 'OG003'}, {'value': '95350', 'spread': '13817', 'groupId': 'OG004'}, {'value': '244300', 'spread': '84238', 'groupId': 'OG005'}, {'value': '409700', 'spread': '135300', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal (n=7,9,10,10,9,10,10)', 'categories': [{'measurements': [{'value': '4726', 'spread': '1594.5', 'groupId': 'OG000'}, {'value': '11700', 'spread': '4305.5', 'groupId': 'OG001'}, {'value': '49340', 'spread': '10835', 'groupId': 'OG002'}, {'value': '170600', 'spread': '50735', 'groupId': 'OG003'}, {'value': '581000', 'spread': '168820', 'groupId': 'OG004'}, {'value': '1241000', 'spread': '395290', 'groupId': 'OG005'}, {'value': '2848000', 'spread': '779810', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.', 'unitOfMeasure': 'ng*hr/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}, {'type': 'SECONDARY', 'title': 'Back-extrapolated Concentration at Time Zero (C0) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}], 'classes': [{'title': 'C-terminal', 'categories': [{'measurements': [{'value': '116.7', 'spread': '47.581', 'groupId': 'OG000'}, {'value': '363.0', 'spread': '81.903', 'groupId': 'OG001'}]}]}, {'title': 'N-terminal', 'categories': [{'measurements': [{'value': '131.8', 'spread': '47.543', 'groupId': 'OG000'}, {'value': '415.4', 'spread': '81.456', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0.25 H post-dose to Bo on Day 1', 'description': 'C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than \\[\\<\\] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. C0 was calculated for cohort 1 (group: PF-05231023 0.5 mg) and 2 (group: PF-05231023 1.5 mg) only as per planned analysis, hence results for the same reported.'}, {'type': 'SECONDARY', 'title': 'Volume of Distribution at Steady State (Vss) of PF-05231023', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}, {'value': '10', 'groupId': 'OG005'}, {'value': '10', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'OG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'OG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'OG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}], 'classes': [{'title': 'C-terminal (n=2,10,10,9,10,10,10)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data was not reported since less than 3 participants were evaluable.', 'groupId': 'OG000'}, {'value': '4.897', 'spread': '0.9277', 'groupId': 'OG001'}, {'value': '4.596', 'spread': '1.2589', 'groupId': 'OG002'}, {'value': '5.023', 'spread': '0.96722', 'groupId': 'OG003'}, {'value': '5.650', 'spread': '1.9178', 'groupId': 'OG004'}, {'value': '4.082', 'spread': '1.1896', 'groupId': 'OG005'}, {'value': '4.655', 'spread': '1.0748', 'groupId': 'OG006'}]}]}, {'title': 'N-terminal (n=7,9,10,10,9,10,10)', 'categories': [{'measurements': [{'value': '4.544', 'spread': '0.81713', 'groupId': 'OG000'}, {'value': '6.151', 'spread': '1.1762', 'groupId': 'OG001'}, {'value': '7.165', 'spread': '1.4032', 'groupId': 'OG002'}, {'value': '7.322', 'spread': '1.2447', 'groupId': 'OG003'}, {'value': '7.022', 'spread': '1.4714', 'groupId': 'OG004'}, {'value': '7.004', 'spread': '1.4774', 'groupId': 'OG005'}, {'value': '7.197', 'spread': '1.4347', 'groupId': 'OG006'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Vss was calculated by dividing the area under the first moment curve from time zero to infinity \\[AUMC(0-∞)\\] with the product of area under the curve from time zero to extrapolated infinite time \\[AUC (0 - ∞)\\] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis set included all participants randomized and treated who have at least 1 of the PK parameters of primary interest. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. 'n' signifies participants who were evaluable for each specified parameter for each arm, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'FG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'FG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'FG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'FG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'FG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'FG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'FG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '10'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '10'}, {'groupId': 'FG007', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants with a historical diagnosis of type 2 diabetes mellitus (T2DM), diagnosed according to the American Diabetes Association (ADA) guidelines and those with well-controlled diabetes were recruited in the study.', 'preAssignmentDetails': "Dose of PF-05231023 was escalated based on sponsor's and investigator's discretion, depending upon safety, tolerability and pharmacokinetic profile of PF-05231023."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}, {'value': '14', 'groupId': 'BG007'}, {'value': '84', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-05231023 0.5 mg', 'description': 'Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.'}, {'id': 'BG001', 'title': 'PF-05231023 1.5 mg', 'description': 'Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.'}, {'id': 'BG002', 'title': 'PF-05231023 5 mg', 'description': 'Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG003', 'title': 'PF-05231023 15 mg', 'description': 'Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG004', 'title': 'PF-05231023 50 mg', 'description': 'Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG005', 'title': 'PF-05231023 100 mg', 'description': 'Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG006', 'title': 'PF-05231023 200 mg', 'description': 'Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG007', 'title': 'Placebo', 'description': 'Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '58.4', 'spread': '3.9', 'groupId': 'BG001'}, {'value': '53.8', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '53.3', 'spread': '8.2', 'groupId': 'BG003'}, {'value': '54.5', 'spread': '8.6', 'groupId': 'BG004'}, {'value': '55.2', 'spread': '7.3', 'groupId': 'BG005'}, {'value': '57.2', 'spread': '5.7', 'groupId': 'BG006'}, {'value': '52.9', 'spread': '6.8', 'groupId': 'BG007'}, {'value': '55.5', 'spread': '6.8', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '5', 'groupId': 'BG007'}, {'value': '24', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}, {'value': '60', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-27', 'studyFirstSubmitDate': '2011-01-26', 'resultsFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2011-01-26', 'lastUpdatePostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-27', 'studyFirstPostDateStruct': {'date': '2011-01-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Abnormal Physical Examination Findings', 'timeFrame': 'Day -1 up to Day 22', 'description': "Physical examination included assessment of height, weight, blood pressure and pulse rate. Criteria for abnormal physical findings was based on investigator's discretion and were reported as adverse event (AE), as planned."}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 up to Day 22', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 22 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values', 'timeFrame': 'Day -1 up to Day 15', 'description': 'Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (RBCs)(less than \\[\\<\\] 0.8\\*lower limit of normal\\[LLN\\]); leucocytes (\\<0.6/greater than \\[\\>\\]1.5\\*upper limit of normal \\[ULN\\]); platelets (\\<0.5\\*LLN/\\>1.75\\*ULN); neutrophils, lymphocytes (\\<0.8\\*LLN/\\>1.2\\*ULN); eosinophils, basophils, monocytes (\\>1.2\\*ULN); total bilirubin, direct bilirubin, indirect bilirubin (\\>1.5\\*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (\\>3\\*ULN), total protein, albumin (\\<0.8\\*LLN/\\>1.2\\*ULN); creatinine, urea (\\>1.3\\*ULN); glucose (\\<0.6\\*LLN/\\>1.5\\*ULN); uric acid (\\>1.2\\*ULN); sodium, potassium, chloride, calcium, bicarbonate (\\<0.9\\*LLN/\\>1.1\\*ULN); urine RBCs, urine white blood cells (WBCs) (\\> or equal\\[=\\]20 high-powered field), urine bacteria \\>20 high-powered field. Total number of participants with any laboratory abnormalities was reported.'}, {'measure': 'Number of Participants With Vital Signs Abnormalities', 'timeFrame': 'Day 1 up to Day 15', 'description': 'Criteria for vital signs abnormalities: supine systolic blood pressure (SBP) \\<90 millimeter of mercury (mmHg), supine diastolic BP (DBP) \\<50 mmHg, supine pulse rate \\<40 beats per minute (bpm). Maximum increase or decrease from baseline in supine SBP \\>=30 mmHg and maximum increase or decrease from baseline in supine DBP \\>=20 mmHg.'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'Screening up to Day 15', 'description': "Criteria for potential clinical concern in ECG parameters: maximum PR interval of greater than or equal to (\\>=) 300 milliseconds (msec), maximum QRS interval \\>=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to \\<480 msec, 480 to \\<500 msec and \\>=500 msec, maximum increase of \\>=25 percent (%) for baseline value of \\>200 msec for PR interval and maximum increase of \\>=50% for baseline value of less than or equal to (\\<=) 200 msec for QRS interval, maximum increase from baseline of \\>=30 msec to \\<60 msec and maximum increase from baseline of \\>60 msec in QTCF interval (Fridericia's Correction)."}, {'measure': 'Number of Participants With Hypoglycemic Adverse Event Based on Capillary Glucose Levels', 'timeFrame': 'Day 0 up to Day 22', 'description': 'Capillary blood glucose levels were collected to observe any hypoglycemic adverse events. Hypoglycemia was assessed as following categories; Severe hypoglycemia (1. Participant was unable to treat himself/herself, requiring assistance of another person to actively administer carbohydrate, glucagon 2. Exhibited one of following neurological symptoms memory loss, uncontrollable behavior, irrational behavior, unusual difficulty in awakening, suspected seizure, seizure or loss of consciousness, 3. Glucose \\<50 mg/dL confirmed on repeat measure); Documented symptomatic hypoglycemia (1. Symptoms of hypoglycaemia accompanied by a measured glucose concentration \\<=70 mg/dL); asymptomatic hypoglycemia (not accompanied by typical symptoms of hypoglycaemia but with a measured glucose concentration \\<=70 mg/dL), and probable hypoglycemia (typical symptoms of hypoglycaemia are not accompanied by a glucose determination, but was presumably caused by a plasma glucose concentration \\<=70 mg/dL).'}, {'measure': 'Number of Participants With Blood Glucose Abnormalities', 'timeFrame': 'Day -1 up to Day 15', 'description': 'Criteria for blood glucose abnormality: Blood glucose levels \\<0.6\\*lower limit of normal (LLN) or \\>1.5\\*upper limit of normal (ULN).'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 1', 'timeFrame': 'Day 1', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 8', 'timeFrame': 'Day 8', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 15', 'timeFrame': 'Day 15', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 22', 'timeFrame': 'Day 22', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.'}, {'measure': 'Number of Participants With Anti-Drug Antibodies (ADA): Day 34', 'timeFrame': 'Day 34', 'description': 'Assays for the determination of human anti-drug (Anti-PF-05231023) antibodies (ADA) was performed.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 1', 'timeFrame': 'Day 1', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich (enzyme-linked immunosorbent assay) ELISA method.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 2', 'timeFrame': 'Day 2', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 3', 'timeFrame': 'Day 3', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 5', 'timeFrame': 'Day 5', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 7', 'timeFrame': 'Day 7', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.'}, {'measure': 'Insulin-like Growth Factor - 1 (IGF-1), Insulin-like Growth Factor Binding Protein-1 (IGFBP-1), Insulin-like Growth Factor Binding Protein-2 (IGFBP-2), Growth Hormone (GH) Levels: Day 15', 'timeFrame': 'Day 15', 'description': 'Plasma samples for IGF-1, and GH were analyzed using a validated, sensitive, and specific immunochromatographic membrane assay (ICMA) fluorescence method. Plasma samples for IGFBP-1, IGFBP-2 were assayed using a validated, sensitive, and specific colorimetric sandwich ELISA method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 1', 'timeFrame': 'Day 1', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 2', 'timeFrame': 'Day 2', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 3', 'timeFrame': 'Day 3', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 5', 'timeFrame': 'Day 5', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 7', 'timeFrame': 'Day 7', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels: Day 15', 'timeFrame': 'Day 15', 'description': 'Plasma samples were assayed using a validated, sensitive, and specific ICMA fluorescence method.'}, {'measure': 'Number of Participants With Abnormal Cardiac Rhythms Recorded by Telemetry', 'timeFrame': 'From 2 hours (H) pre-dose for intravenous bolus or 2 H prior to the start of infusion on Day 1 up to 8 H post-dose for bolus or 8 H following the end of the infusion on Day 1', 'description': "Criteria for abnormal cardiac rhythms was based on investigator's discretion and were reported as adverse event (AE), as planned."}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Time of Last Quantifiable Plasma Concentration (AUClast) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast).\n\nParticipants who received PF-05231023 with C-terminal and N-terminal AUClast were reported.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Participants who received PF-05231023 with C-terminal and N-terminal Tmax were reported.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Participants who received PF-05231023 with C-terminal and N-terminal Cmax were reported.'}, {'measure': 'Plasma Terminal Half-Life (t1/2) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half at the terminal phase. Participants who received PF-05231023 with C-terminal and N-terminal t1/2 were reported.'}, {'measure': 'Apparent Clearance (CL) of PF-05231023 for Intravenous Bolus Dosing', 'timeFrame': 'Hour (H)-1 (1 H pre-dose to bolus [Bo]),H-0.5(0.5 H pre-dose to Bo),H 0 (prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.Participants who received PF-05231023 with C-terminal and N-terminal CL were reported.'}, {'measure': 'Apparent Volume of Distribution (Vz) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. PF-05231023 with C-terminal and N-terminal Vz were reported.'}, {'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'AUC (0 - ∞)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞). PF-05231023 with C-terminal and N-terminal AUC (0 - ∞) were reported.'}, {'measure': 'Back-extrapolated Concentration at Time Zero (C0) of PF-05231023', 'timeFrame': '0.25 H post-dose to Bo on Day 1', 'description': 'C0 was estimated by back-extrapolating from the first 2 concentration values using the log-linear regression on the first 2 data points (where second concentration was less than \\[\\<\\] first concentration) to back-extrapolate C0. PF-05231023 with C-terminal and N-terminal C0 were reported.'}, {'measure': 'Volume of Distribution at Steady State (Vss) of PF-05231023', 'timeFrame': 'Hour(H)-1(prior to start of infusion[In] or 1 H pre-dose to bolus[Bo]),H-0.5(0.5 H post start of In or 0.5 H pre-dose to Bo),H 0(end of In or prior to Bo),0.25,0.5,1,1.5,2,3,5,8,12 H post end of In or post-dose to Bo on Day 1;Day 2,3,4,5,6,8,15,22', 'description': 'Vss was calculated by dividing the area under the first moment curve from time zero to infinity \\[AUMC(0-∞)\\] with the product of area under the curve from time zero to extrapolated infinite time \\[AUC (0 - ∞)\\] and apparent clearance (CL). PF-05231023 with C-terminal and N-terminal Vss were reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes', 'intravenous', 'single dose'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2901001&StudyName=Safety%20And%20Tolerability%20Of%20Escalating%20Intravenous%20Doses%20Of%20PF-05231023%20In%20Adult%20Subjects%20With%20Type%202%20Diabetes', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a trial in subjects with Type 2 diabetes mellitus to study the safety, tolerability and pharmacokinetics and pharmacodynamics of single escalating doses of PF-05231023.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects between the ages of 30 and 65 years, inclusive, with a historical diagnosis of type 2 diabetes mellitus, diagnosed according to the American Diabetes Association guidelines.\n* Body Mass Index (BMI) of 25 to 35.5 kg/m2, and a total body weight \\>50 kg (110 lbs).\n* HbA1c \\>7% and not to exceed 10.5%.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* Diagnosis of Type 1 diabetes mellitus\n* Evidence of diabetic complications with significant end organ damage.'}, 'identificationModule': {'nctId': 'NCT01285518', 'briefTitle': 'Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Intravenous Doses Of Pf-05231023 In Adult Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'B2901001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'interventionNames': ['Drug: PF-05231023']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '0.9% w/v sodium chloride injection, USP', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'PF-05231023', 'type': 'DRUG', 'description': '0.5 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '1.5 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '5 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '15 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '50 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '100 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'PF-05231023', 'type': 'DRUG', 'description': '200 mg QD IV x 1 day', 'armGroupLabels': ['Treatment']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% w/v sodium chloride injection, USP QD IVx 1 day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91911', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Profil Institute for Clinical Research, Inc.', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '33901', 'city': 'Fort Meyers', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)'}, {'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Elite Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Comprehensive Phase One (A Division of Comprehensive NeuroScience, Inc.)', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}