Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT01272804
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2011-01-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multiple Dose Study Of PF-04937319 In Patients 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': 'C000598526', 'term': 'N,N-dimethyl-5-((2-methyl-6-((5-methylpyrazin-2-yl)carbamoyl)benzofuran-4-yl)oxy)pyrimidine-2-carboxamide'}]}}, '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}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 6, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.', 'otherNumAtRisk': 9, 'otherNumAffected': 8, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.', 'otherNumAtRisk': 16, 'otherNumAffected': 5, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Infected sebaceous cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Blood glucose decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Micturition urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 14.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}]}, {'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'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)', '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 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) On Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.22', 'spread': '25', 'groupId': 'OG000'}, {'value': '69.49', 'spread': '32', 'groupId': 'OG001'}, {'value': '119.4', 'spread': '38', 'groupId': 'OG002'}, {'value': '245.4', 'spread': '42', 'groupId': 'OG003'}, {'value': '449.3', 'spread': '39', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) On Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.73', 'spread': '17', 'groupId': 'OG000'}, {'value': '122.3', 'spread': '17', 'groupId': 'OG001'}, {'value': '234.1', 'spread': '24', 'groupId': 'OG002'}, {'value': '421.5', 'spread': '31', 'groupId': 'OG003'}, {'value': '970.6', 'spread': '35', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.95', 'upperLimit': '5.00'}, {'value': '3.00', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '5.00'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '1.50', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '5.05'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '5.00'}, {'value': '1.50', 'groupId': 'OG002', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '1.50', 'upperLimit': '5.00'}, {'value': '1.50', 'groupId': 'OG004', 'lowerLimit': '0.50', 'upperLimit': '5.07'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '407.0', 'spread': '29', 'groupId': 'OG000'}, {'value': '867.7', 'spread': '21', 'groupId': 'OG001'}, {'value': '1456', 'spread': '48', 'groupId': 'OG002'}, {'value': '2749', 'spread': '38', 'groupId': 'OG003'}, {'value': '6034', 'spread': '40', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)', 'description': 'AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.09', 'spread': '27', 'groupId': 'OG000'}, {'value': '79.30', 'spread': '31', 'groupId': 'OG001'}, {'value': '171.3', 'spread': '36', 'groupId': 'OG002'}, {'value': '251.5', 'spread': '44', 'groupId': 'OG003'}, {'value': '555.9', 'spread': '44', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '3.02'}, {'value': '3.00', 'groupId': 'OG001', 'lowerLimit': '1.50', 'upperLimit': '8.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '8.00'}, {'value': '3.00', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '8.00'}, {'value': '3.00', 'groupId': 'OG004', 'lowerLimit': '3.00', 'upperLimit': '8.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '458.0', 'spread': '35', 'groupId': 'OG000'}, {'value': '928.7', 'spread': '23', 'groupId': 'OG001'}, {'value': '1889', 'spread': '52', 'groupId': 'OG002'}, {'value': '3167', 'spread': '40', 'groupId': 'OG003'}, {'value': '7446', 'spread': '42', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'description': 'AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.', 'unitOfMeasure': 'nanogram*hour per milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Plasma Decay Half-Life (t1/2) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.563', 'spread': '0.77897', 'groupId': 'OG000'}, {'value': '6.884', 'spread': '1.9264', 'groupId': 'OG001'}, {'value': '6.348', 'spread': '1.4271', 'groupId': 'OG002'}, {'value': '6.960', 'spread': '1.0358', 'groupId': 'OG003'}, {'value': '8.479', 'spread': '2.4173', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.380', 'spread': '83', 'groupId': 'OG000'}, {'value': '10.56', 'spread': '43', 'groupId': 'OG001'}, {'value': '22.73', 'spread': '103', 'groupId': 'OG002'}, {'value': '41.68', 'spread': '64', 'groupId': 'OG003'}, {'value': '129.8', 'spread': '62', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3904', 'spread': '0.11901', 'groupId': 'OG000'}, {'value': '0.3533', 'spread': '0.20183', 'groupId': 'OG001'}, {'value': '0.6463', 'spread': '0.56717', 'groupId': 'OG002'}, {'value': '0.5380', 'spread': '0.34593', 'groupId': 'OG003'}, {'value': '0.4294', 'spread': '0.44676', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 hour (pre-dose) through 24 hours post-dose on Day 14', 'description': 'Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.', 'unitOfMeasure': 'percentage of dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Apparent Oral Clearance (CL/F) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.86', 'spread': '25', 'groupId': 'OG000'}, {'value': '32.32', 'spread': '23', 'groupId': 'OG001'}, {'value': '26.48', 'spread': '34', 'groupId': 'OG002'}, {'value': '31.56', 'spread': '37', 'groupId': 'OG003'}, {'value': '40.29', 'spread': '43', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.', 'unitOfMeasure': 'liter per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vz/F) on Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '205.3', 'spread': '20', 'groupId': 'OG000'}, {'value': '311.6', 'spread': '32', 'groupId': 'OG001'}, {'value': '236.7', 'spread': '27', 'groupId': 'OG002'}, {'value': '314.0', 'spread': '28', 'groupId': 'OG003'}, {'value': '475.2', 'spread': '48', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', '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.', 'unitOfMeasure': 'liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Observed Accumulation Ratio for AUCtau (Rac)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.204', 'spread': '22', 'groupId': 'OG000'}, {'value': '1.069', 'spread': '15', 'groupId': 'OG001'}, {'value': '1.296', 'spread': '24', 'groupId': 'OG002'}, {'value': '1.152', 'spread': '22', 'groupId': 'OG003'}, {'value': '1.118', 'spread': '40', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)', 'description': 'Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Observed Accumulation Ratio for Cmax (Rac, Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.414', 'spread': '41', 'groupId': 'OG000'}, {'value': '1.141', 'spread': '28', 'groupId': 'OG001'}, {'value': '1.437', 'spread': '17', 'groupId': 'OG002'}, {'value': '1.026', 'spread': '25', 'groupId': 'OG003'}, {'value': '1.080', 'spread': '40', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)', 'description': 'Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': "PK parameter analysis population included all enrolled participants treated with PF-04937319 who had at least 1 of the PK parameters of interest. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.46', 'spread': '8.881', 'groupId': 'OG000'}, {'value': '-2.67', 'spread': '6.670', 'groupId': 'OG001'}, {'value': '6.41', 'spread': '14.532', 'groupId': 'OG002'}, {'value': '-12.11', 'spread': '14.225', 'groupId': 'OG003'}, {'value': '-12.29', 'spread': '13.711', 'groupId': 'OG004'}, {'value': '-3.71', 'spread': '10.848', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamic (PD) analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter.'}, {'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.94', 'spread': '15.477', 'groupId': 'OG000'}, {'value': '-4.91', 'spread': '16.601', 'groupId': 'OG001'}, {'value': '-4.11', 'spread': '17.321', 'groupId': 'OG002'}, {'value': '-26.83', 'spread': '21.054', 'groupId': 'OG003'}, {'value': '-11.37', 'spread': '15.205', 'groupId': 'OG004'}, {'value': '-2.86', 'spread': '12.103', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Percent Change at Day 1 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-2.22', 'spread': '17.843', 'groupId': 'OG000'}, {'value': '13.24', 'spread': '22.221', 'groupId': 'OG001'}, {'value': '24.11', 'spread': '13.772', 'groupId': 'OG002'}, {'value': '4.41', 'spread': '17.470', 'groupId': 'OG003'}, {'value': '18.10', 'spread': '17.059', 'groupId': 'OG004'}, {'value': '-2.92', 'spread': '15.768', 'groupId': 'OG005'}]}]}, {'title': 'Percent Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '15.77', 'spread': '21.452', 'groupId': 'OG000'}, {'value': '17.98', 'spread': '26.499', 'groupId': 'OG001'}, {'value': '30.86', 'spread': '41.063', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '21.140', 'groupId': 'OG003'}, {'value': '39.23', 'spread': '26.876', 'groupId': 'OG004'}, {'value': '7.62', 'spread': '26.034', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Percent Change at Day 1 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-2.36', 'spread': '10.170', 'groupId': 'OG000'}, {'value': '8.53', 'spread': '13.383', 'groupId': 'OG001'}, {'value': '12.65', 'spread': '9.974', 'groupId': 'OG002'}, {'value': '2.37', 'spread': '12.421', 'groupId': 'OG003'}, {'value': '16.34', 'spread': '8.940', 'groupId': 'OG004'}, {'value': '-1.43', 'spread': '9.488', 'groupId': 'OG005'}]}]}, {'title': 'Percent Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '8.66', 'spread': '11.069', 'groupId': 'OG000'}, {'value': '13.49', 'spread': '14.403', 'groupId': 'OG001'}, {'value': '16.51', 'spread': '27.962', 'groupId': 'OG002'}, {'value': '-1.44', 'spread': '14.463', 'groupId': 'OG003'}, {'value': '22.50', 'spread': '14.809', 'groupId': 'OG004'}, {'value': '1.80', 'spread': '16.722', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Plasma Glucose at Day 1, 6, 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '192.10', 'spread': '22.913', 'groupId': 'OG000'}, {'value': '188.83', 'spread': '48.992', 'groupId': 'OG001'}, {'value': '195.78', 'spread': '37.871', 'groupId': 'OG002'}, {'value': '205.38', 'spread': '44.632', 'groupId': 'OG003'}, {'value': '170.95', 'spread': '51.465', 'groupId': 'OG004'}, {'value': '189.07', 'spread': '39.131', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 1 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-7.18', 'spread': '9.851', 'groupId': 'OG000'}, {'value': '-5.24', 'spread': '6.421', 'groupId': 'OG001'}, {'value': '8.72', 'spread': '15.071', 'groupId': 'OG002'}, {'value': '-1.90', 'spread': '21.784', 'groupId': 'OG003'}, {'value': '-23.26', 'spread': '19.189', 'groupId': 'OG004'}, {'value': '3.04', 'spread': '17.611', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-19.62', 'spread': '16.247', 'groupId': 'OG000'}, {'value': '-6.35', 'spread': '22.496', 'groupId': 'OG001'}, {'value': '9.80', 'spread': '30.359', 'groupId': 'OG002'}, {'value': '-32.36', 'spread': '24.121', 'groupId': 'OG003'}, {'value': '-47.19', 'spread': '25.752', 'groupId': 'OG004'}, {'value': '3.92', 'spread': '17.068', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-12.65', 'spread': '25.918', 'groupId': 'OG000'}, {'value': '-16.45', 'spread': '27.709', 'groupId': 'OG001'}, {'value': '-14.79', 'spread': '33.687', 'groupId': 'OG002'}, {'value': '-48.87', 'spread': '27.216', 'groupId': 'OG003'}, {'value': '-34.15', 'spread': '24.596', 'groupId': 'OG004'}, {'value': '-7.48', 'spread': '21.703', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14', 'description': 'Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \\[0-24\\]) divided by 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '173.78', 'spread': '31.952', 'groupId': 'OG000'}, {'value': '181.33', 'spread': '50.621', 'groupId': 'OG001'}, {'value': '190.11', 'spread': '34.505', 'groupId': 'OG002'}, {'value': '193.67', 'spread': '45.695', 'groupId': 'OG003'}, {'value': '162.33', 'spread': '50.269', 'groupId': 'OG004'}, {'value': '172.44', 'spread': '42.527', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 2 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-5.00', 'spread': '10.840', 'groupId': 'OG000'}, {'value': '-4.67', 'spread': '12.845', 'groupId': 'OG001'}, {'value': '-6.78', 'spread': '25.430', 'groupId': 'OG002'}, {'value': '-1.78', 'spread': '14.507', 'groupId': 'OG003'}, {'value': '-23.44', 'spread': '18.662', 'groupId': 'OG004'}, {'value': '0.94', 'spread': '12.588', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 3 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-19.11', 'spread': '10.216', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '10.171', 'groupId': 'OG001'}, {'value': '-18.78', 'spread': '27.124', 'groupId': 'OG002'}, {'value': '-13.22', 'spread': '15.571', 'groupId': 'OG003'}, {'value': '-32.78', 'spread': '17.527', 'groupId': 'OG004'}, {'value': '-7.81', 'spread': '16.885', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 4 (n=9,9,9,9,8,16)', 'categories': [{'measurements': [{'value': '-13.44', 'spread': '19.603', 'groupId': 'OG000'}, {'value': '-9.44', 'spread': '16.001', 'groupId': 'OG001'}, {'value': '-13.78', 'spread': '28.900', 'groupId': 'OG002'}, {'value': '-19.67', 'spread': '20.899', 'groupId': 'OG003'}, {'value': '-42.88', 'spread': '20.972', 'groupId': 'OG004'}, {'value': '-4.13', 'spread': '18.722', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 5 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-19.67', 'spread': '16.256', 'groupId': 'OG000'}, {'value': '-9.89', 'spread': '15.358', 'groupId': 'OG001'}, {'value': '-22.56', 'spread': '29.560', 'groupId': 'OG002'}, {'value': '-26.56', 'spread': '21.030', 'groupId': 'OG003'}, {'value': '-30.33', 'spread': '22.170', 'groupId': 'OG004'}, {'value': '-14.06', 'spread': '21.402', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-10.89', 'spread': '18.210', 'groupId': 'OG000'}, {'value': '-16.33', 'spread': '17.804', 'groupId': 'OG001'}, {'value': '-18.00', 'spread': '34.380', 'groupId': 'OG002'}, {'value': '-29.11', 'spread': '16.027', 'groupId': 'OG003'}, {'value': '-43.00', 'spread': '15.610', 'groupId': 'OG004'}, {'value': '-8.27', 'spread': '12.708', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 7 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-13.50', 'spread': '21.314', 'groupId': 'OG000'}, {'value': '-12.78', 'spread': '13.664', 'groupId': 'OG001'}, {'value': '-14.44', 'spread': '37.270', 'groupId': 'OG002'}, {'value': '-30.22', 'spread': '16.672', 'groupId': 'OG003'}, {'value': '-43.71', 'spread': '18.117', 'groupId': 'OG004'}, {'value': '-5.60', 'spread': '12.704', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 8 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-23.25', 'spread': '21.212', 'groupId': 'OG000'}, {'value': '-8.56', 'spread': '20.415', 'groupId': 'OG001'}, {'value': '-5.56', 'spread': '37.964', 'groupId': 'OG002'}, {'value': '-24.11', 'spread': '19.934', 'groupId': 'OG003'}, {'value': '-31.71', 'spread': '20.155', 'groupId': 'OG004'}, {'value': '-4.93', 'spread': '16.434', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 9 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-19.63', 'spread': '20.784', 'groupId': 'OG000'}, {'value': '-22.11', 'spread': '20.709', 'groupId': 'OG001'}, {'value': '-9.78', 'spread': '42.825', 'groupId': 'OG002'}, {'value': '-24.78', 'spread': '17.817', 'groupId': 'OG003'}, {'value': '-38.00', 'spread': '19.502', 'groupId': 'OG004'}, {'value': '-2.80', 'spread': '15.857', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 10 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-23.88', 'spread': '23.503', 'groupId': 'OG000'}, {'value': '-16.89', 'spread': '20.847', 'groupId': 'OG001'}, {'value': '-16.33', 'spread': '32.427', 'groupId': 'OG002'}, {'value': '-37.11', 'spread': '19.877', 'groupId': 'OG003'}, {'value': '-34.29', 'spread': '24.452', 'groupId': 'OG004'}, {'value': '-6.20', 'spread': '10.544', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 11 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-17.38', 'spread': '28.540', 'groupId': 'OG000'}, {'value': '-22.56', 'spread': '22.490', 'groupId': 'OG001'}, {'value': '-18.11', 'spread': '39.810', 'groupId': 'OG002'}, {'value': '-32.89', 'spread': '20.294', 'groupId': 'OG003'}, {'value': '-38.57', 'spread': '22.240', 'groupId': 'OG004'}, {'value': '-5.73', 'spread': '19.374', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 12 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-27.13', 'spread': '28.423', 'groupId': 'OG000'}, {'value': '-18.56', 'spread': '28.183', 'groupId': 'OG001'}, {'value': '-16.89', 'spread': '41.870', 'groupId': 'OG002'}, {'value': '-32.22', 'spread': '17.880', 'groupId': 'OG003'}, {'value': '-43.57', 'spread': '26.576', 'groupId': 'OG004'}, {'value': '-7.73', 'spread': '17.910', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 13 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-18.13', 'spread': '30.258', 'groupId': 'OG000'}, {'value': '-23.44', 'spread': '23.807', 'groupId': 'OG001'}, {'value': '-24.78', 'spread': '40.822', 'groupId': 'OG002'}, {'value': '-30.89', 'spread': '19.548', 'groupId': 'OG003'}, {'value': '-39.71', 'spread': '22.706', 'groupId': 'OG004'}, {'value': '-12.27', 'spread': '18.718', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-33.63', 'spread': '26.175', 'groupId': 'OG000'}, {'value': '-23.67', 'spread': '25.441', 'groupId': 'OG001'}, {'value': '-26.56', 'spread': '39.768', 'groupId': 'OG002'}, {'value': '-43.78', 'spread': '22.725', 'groupId': 'OG003'}, {'value': '-41.86', 'spread': '22.386', 'groupId': 'OG004'}, {'value': '-11.80', 'spread': '16.545', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 15 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-13.38', 'spread': '22.595', 'groupId': 'OG000'}, {'value': '-21.44', 'spread': '26.034', 'groupId': 'OG001'}, {'value': '-23.89', 'spread': '38.238', 'groupId': 'OG002'}, {'value': '-44.11', 'spread': '19.586', 'groupId': 'OG003'}, {'value': '-40.57', 'spread': '25.553', 'groupId': 'OG004'}, {'value': '-11.47', 'spread': '17.916', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '178.89', 'spread': '63.21', 'groupId': 'OG000'}, {'value': '152.33', 'spread': '43.88', 'groupId': 'OG001'}, {'value': '175.56', 'spread': '53.32', 'groupId': 'OG002'}, {'value': '192.78', 'spread': '91.62', 'groupId': 'OG003'}, {'value': '123.33', 'spread': '47.89', 'groupId': 'OG004'}, {'value': '152.31', 'spread': '70.46', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 3 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-5.89', 'spread': '82.19', 'groupId': 'OG000'}, {'value': '1.67', 'spread': '63.16', 'groupId': 'OG001'}, {'value': '-44.44', 'spread': '45.88', 'groupId': 'OG002'}, {'value': '-25.44', 'spread': '59.99', 'groupId': 'OG003'}, {'value': '0.22', 'spread': '42.40', 'groupId': 'OG004'}, {'value': '0.88', 'spread': '47.31', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-32.00', 'spread': '70.40', 'groupId': 'OG000'}, {'value': '-1.33', 'spread': '65.02', 'groupId': 'OG001'}, {'value': '-40.44', 'spread': '50.85', 'groupId': 'OG002'}, {'value': '-29.00', 'spread': '62.90', 'groupId': 'OG003'}, {'value': '13.14', 'spread': '51.50', 'groupId': 'OG004'}, {'value': '-14.67', 'spread': '51.85', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 10 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-16.88', 'spread': '58.15', 'groupId': 'OG000'}, {'value': '1.78', 'spread': '66.28', 'groupId': 'OG001'}, {'value': '-6.44', 'spread': '59.39', 'groupId': 'OG002'}, {'value': '-13.56', 'spread': '51.83', 'groupId': 'OG003'}, {'value': '30.71', 'spread': '43.77', 'groupId': 'OG004'}, {'value': '2.13', 'spread': '46.04', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-19.25', 'spread': '76.20', 'groupId': 'OG000'}, {'value': '-4.44', 'spread': '65.79', 'groupId': 'OG001'}, {'value': '-37.33', 'spread': '48.75', 'groupId': 'OG002'}, {'value': '-40.33', 'spread': '55.72', 'groupId': 'OG003'}, {'value': '15.57', 'spread': '38.25', 'groupId': 'OG004'}, {'value': '-21.67', 'spread': '44.03', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 16 (n=8,9,9,9,7,14)', 'categories': [{'measurements': [{'value': '13.25', 'spread': '108.99', 'groupId': 'OG000'}, {'value': '-6.67', 'spread': '80.27', 'groupId': 'OG001'}, {'value': '-36.22', 'spread': '50.27', 'groupId': 'OG002'}, {'value': '-35.33', 'spread': '53.61', 'groupId': 'OG003'}, {'value': '23.57', 'spread': '50.04', 'groupId': 'OG004'}, {'value': '-19.07', 'spread': '47.96', 'groupId': 'OG005'}]}]}, {'title': 'Change at Follow-up (n=9,9,9,9,7,16)', 'categories': [{'measurements': [{'value': '-41.22', 'spread': '73.73', 'groupId': 'OG000'}, {'value': '38.78', 'spread': '163.30', 'groupId': 'OG001'}, {'value': '4.56', 'spread': '73.52', 'groupId': 'OG002'}, {'value': '-45.44', 'spread': '120.43', 'groupId': 'OG003'}, {'value': '22.29', 'spread': '57.79', 'groupId': 'OG004'}, {'value': '1.94', 'spread': '52.43', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '200.56', 'spread': '34.32', 'groupId': 'OG000'}, {'value': '207.33', 'spread': '41.11', 'groupId': 'OG001'}, {'value': '205.00', 'spread': '50.52', 'groupId': 'OG002'}, {'value': '213.22', 'spread': '53.38', 'groupId': 'OG003'}, {'value': '170.22', 'spread': '41.37', 'groupId': 'OG004'}, {'value': '181.94', 'spread': '34.45', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 3 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-24.00', 'spread': '17.21', 'groupId': 'OG000'}, {'value': '-9.33', 'spread': '13.46', 'groupId': 'OG001'}, {'value': '-14.22', 'spread': '16.93', 'groupId': 'OG002'}, {'value': '-16.33', 'spread': '18.33', 'groupId': 'OG003'}, {'value': '-11.56', 'spread': '31.13', 'groupId': 'OG004'}, {'value': '-7.50', 'spread': '18.40', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-19.11', 'spread': '20.95', 'groupId': 'OG000'}, {'value': '-25.11', 'spread': '19.47', 'groupId': 'OG001'}, {'value': '-20.78', 'spread': '19.39', 'groupId': 'OG002'}, {'value': '-11.33', 'spread': '21.17', 'groupId': 'OG003'}, {'value': '0.00', 'spread': '42.90', 'groupId': 'OG004'}, {'value': '-6.47', 'spread': '26.19', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 10 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-30.00', 'spread': '24.51', 'groupId': 'OG000'}, {'value': '-14.67', 'spread': '14.40', 'groupId': 'OG001'}, {'value': '-30.89', 'spread': '17.41', 'groupId': 'OG002'}, {'value': '-15.11', 'spread': '20.76', 'groupId': 'OG003'}, {'value': '-2.29', 'spread': '41.43', 'groupId': 'OG004'}, {'value': '0.33', 'spread': '30.00', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-31.50', 'spread': '21.08', 'groupId': 'OG000'}, {'value': '-29.11', 'spread': '14.42', 'groupId': 'OG001'}, {'value': '-27.44', 'spread': '17.08', 'groupId': 'OG002'}, {'value': '-24.22', 'spread': '25.73', 'groupId': 'OG003'}, {'value': '1.29', 'spread': '41.63', 'groupId': 'OG004'}, {'value': '-6.60', 'spread': '37.37', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 16 (n=8,9,9,9,7,14)', 'categories': [{'measurements': [{'value': '-26.38', 'spread': '26.72', 'groupId': 'OG000'}, {'value': '-22.11', 'spread': '13.60', 'groupId': 'OG001'}, {'value': '-29.11', 'spread': '20.26', 'groupId': 'OG002'}, {'value': '-12.11', 'spread': '24.49', 'groupId': 'OG003'}, {'value': '1.86', 'spread': '45.05', 'groupId': 'OG004'}, {'value': '-1.43', 'spread': '32.90', 'groupId': 'OG005'}]}]}, {'title': 'Change at Follow-up (n=9,9,9,9,7,16)', 'categories': [{'measurements': [{'value': '-19.44', 'spread': '25.73', 'groupId': 'OG000'}, {'value': '-12.44', 'spread': '24.70', 'groupId': 'OG001'}, {'value': '-29.44', 'spread': '27.13', 'groupId': 'OG002'}, {'value': '-33.56', 'spread': '40.73', 'groupId': 'OG003'}, {'value': '-15.29', 'spread': '8.24', 'groupId': 'OG004'}, {'value': '-5.50', 'spread': '29.57', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '116.67', 'spread': '37.41', 'groupId': 'OG000'}, {'value': '133.56', 'spread': '43.47', 'groupId': 'OG001'}, {'value': '123.44', 'spread': '35.72', 'groupId': 'OG002'}, {'value': '130.67', 'spread': '33.83', 'groupId': 'OG003'}, {'value': '96.11', 'spread': '37.88', 'groupId': 'OG004'}, {'value': '102.44', 'spread': '31.64', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 3 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-19.22', 'spread': '22.22', 'groupId': 'OG000'}, {'value': '-5.89', 'spread': '19.37', 'groupId': 'OG001'}, {'value': '-6.89', 'spread': '15.26', 'groupId': 'OG002'}, {'value': '-6.67', 'spread': '19.46', 'groupId': 'OG003'}, {'value': '-11.00', 'spread': '23.51', 'groupId': 'OG004'}, {'value': '-3.63', 'spread': '14.80', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-8.78', 'spread': '23.21', 'groupId': 'OG000'}, {'value': '-20.44', 'spread': '22.32', 'groupId': 'OG001'}, {'value': '-13.67', 'spread': '14.74', 'groupId': 'OG002'}, {'value': '-2.33', 'spread': '22.11', 'groupId': 'OG003'}, {'value': '-0.29', 'spread': '38.98', 'groupId': 'OG004'}, {'value': '2.73', 'spread': '20.35', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 10 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-19.00', 'spread': '24.94', 'groupId': 'OG000'}, {'value': '-11.44', 'spread': '16.84', 'groupId': 'OG001'}, {'value': '-30.89', 'spread': '14.08', 'groupId': 'OG002'}, {'value': '-7.89', 'spread': '17.92', 'groupId': 'OG003'}, {'value': '-9.57', 'spread': '35.69', 'groupId': 'OG004'}, {'value': '5.07', 'spread': '24.99', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-17.13', 'spread': '21.14', 'groupId': 'OG000'}, {'value': '-22.44', 'spread': '16.49', 'groupId': 'OG001'}, {'value': '-19.89', 'spread': '14.68', 'groupId': 'OG002'}, {'value': '-11.56', 'spread': '17.92', 'groupId': 'OG003'}, {'value': '-1.00', 'spread': '38.18', 'groupId': 'OG004'}, {'value': '4.80', 'spread': '30.59', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 16 (n=8,9,9,9,7,14)', 'categories': [{'measurements': [{'value': '-17.88', 'spread': '22.22', 'groupId': 'OG000'}, {'value': '-15.00', 'spread': '14.11', 'groupId': 'OG001'}, {'value': '-20.22', 'spread': '16.75', 'groupId': 'OG002'}, {'value': '-0.67', 'spread': '16.86', 'groupId': 'OG003'}, {'value': '-3.86', 'spread': '38.21', 'groupId': 'OG004'}, {'value': '5.79', 'spread': '27.50', 'groupId': 'OG005'}]}]}, {'title': 'Change at Follow-up (n=9,8,9,9,7,16)', 'categories': [{'measurements': [{'value': '-6.22', 'spread': '24.40', 'groupId': 'OG000'}, {'value': '-10.38', 'spread': '15.15', 'groupId': 'OG001'}, {'value': '-27.11', 'spread': '22.05', 'groupId': 'OG002'}, {'value': '-19.78', 'spread': '22.97', 'groupId': 'OG003'}, {'value': '-17.43', 'spread': '16.70', 'groupId': 'OG004'}, {'value': '-2.25', 'spread': '23.61', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '48.11', 'spread': '10.96', 'groupId': 'OG000'}, {'value': '43.33', 'spread': '9.51', 'groupId': 'OG001'}, {'value': '46.44', 'spread': '11.51', 'groupId': 'OG002'}, {'value': '43.89', 'spread': '13.66', 'groupId': 'OG003'}, {'value': '49.44', 'spread': '14.05', 'groupId': 'OG004'}, {'value': '48.94', 'spread': '9.33', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 3 (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '-3.56', 'spread': '4.10', 'groupId': 'OG000'}, {'value': '-3.67', 'spread': '6.36', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '6.75', 'groupId': 'OG002'}, {'value': '-4.56', 'spread': '4.07', 'groupId': 'OG003'}, {'value': '-0.67', 'spread': '7.07', 'groupId': 'OG004'}, {'value': '-3.88', 'spread': '8.02', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-4.00', 'spread': '2.65', 'groupId': 'OG000'}, {'value': '-4.33', 'spread': '7.73', 'groupId': 'OG001'}, {'value': '1.00', 'spread': '4.66', 'groupId': 'OG002'}, {'value': '-3.11', 'spread': '3.69', 'groupId': 'OG003'}, {'value': '-2.43', 'spread': '2.64', 'groupId': 'OG004'}, {'value': '-6.20', 'spread': '7.80', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 10 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-7.63', 'spread': '4.21', 'groupId': 'OG000'}, {'value': '-3.44', 'spread': '5.98', 'groupId': 'OG001'}, {'value': '1.22', 'spread': '5.70', 'groupId': 'OG002'}, {'value': '-4.44', 'spread': '3.21', 'groupId': 'OG003'}, {'value': '1.14', 'spread': '4.49', 'groupId': 'OG004'}, {'value': '-5.00', 'spread': '7.99', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-10.50', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '10.59', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '5.15', 'groupId': 'OG002'}, {'value': '-4.44', 'spread': '4.93', 'groupId': 'OG003'}, {'value': '-0.86', 'spread': '4.38', 'groupId': 'OG004'}, {'value': '-6.93', 'spread': '9.52', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 16 (n=8,9,9,9,7,14)', 'categories': [{'measurements': [{'value': '-11.0', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '-5.78', 'spread': '7.61', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '5.70', 'groupId': 'OG002'}, {'value': '-4.22', 'spread': '4.12', 'groupId': 'OG003'}, {'value': '1.00', 'spread': '3.79', 'groupId': 'OG004'}, {'value': '-3.36', 'spread': '9.04', 'groupId': 'OG005'}]}]}, {'title': 'Change at Follow-up (n=9,9,9,9,7,16)', 'categories': [{'measurements': [{'value': '-4.89', 'spread': '3.98', 'groupId': 'OG000'}, {'value': '-5.22', 'spread': '6.50', 'groupId': 'OG001'}, {'value': '-3.22', 'spread': '7.24', 'groupId': 'OG002'}, {'value': '-4.44', 'spread': '6.98', 'groupId': 'OG003'}, {'value': '-2.29', 'spread': '4.07', 'groupId': 'OG004'}, {'value': '-3.50', 'spread': '6.86', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lactate Level at Day 6 and 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '16', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'OG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'OG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'OG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'OG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'classes': [{'title': 'Baseline (n=9,9,9,9,9,16)', 'categories': [{'measurements': [{'value': '17.64', 'spread': '5.14', 'groupId': 'OG000'}, {'value': '10.17', 'spread': '3.07', 'groupId': 'OG001'}, {'value': '14.14', 'spread': '7.82', 'groupId': 'OG002'}, {'value': '21.66', 'spread': '9.45', 'groupId': 'OG003'}, {'value': '11.57', 'spread': '4.30', 'groupId': 'OG004'}, {'value': '14.74', 'spread': '8.58', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 6 (n=9,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '-2.44', 'spread': '7.95', 'groupId': 'OG000'}, {'value': '1.02', 'spread': '1.77', 'groupId': 'OG001'}, {'value': '-2.08', 'spread': '7.14', 'groupId': 'OG002'}, {'value': '-6.08', 'spread': '10.72', 'groupId': 'OG003'}, {'value': '2.61', 'spread': '6.60', 'groupId': 'OG004'}, {'value': '-1.45', 'spread': '9.27', 'groupId': 'OG005'}]}]}, {'title': 'Change at Day 14 (n=8,9,9,9,7,15)', 'categories': [{'measurements': [{'value': '0.21', 'spread': '3.07', 'groupId': 'OG000'}, {'value': '-0.09', 'spread': '2.02', 'groupId': 'OG001'}, {'value': '-3.88', 'spread': '6.63', 'groupId': 'OG002'}, {'value': '-6.97', 'spread': '10.42', 'groupId': 'OG003'}, {'value': '2.60', 'spread': '2.98', 'groupId': 'OG004'}, {'value': '-2.59', 'spread': '8.67', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Day 1), Day 6 and 14', 'description': 'Baseline value was collected at 0 hour on Day 1 for lactate.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 PD parameter. Here 'n' signifies participants evaluable for this measure at specified time point for each arm group, respectively."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'FG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'FG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'FG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'FG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'FG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '16'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '9'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'PF-04937319 10 mg', 'description': 'Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.'}, {'id': 'BG001', 'title': 'PF-04937319 30 mg', 'description': 'Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'BG002', 'title': 'PF-04937319 50 mg', 'description': 'Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.'}, {'id': 'BG003', 'title': 'PF-04937319 100 mg', 'description': 'Participants received PF-04937319 100 mg tablet orally once daily for 14 days.'}, {'id': 'BG004', 'title': 'PF-04937319 300 mg', 'description': 'Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.'}, {'id': 'BG005', 'title': 'Placebo', 'description': 'Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '9.2', 'groupId': 'BG000'}, {'value': '49.4', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '54.2', 'spread': '5.4', 'groupId': 'BG002'}, {'value': '51.4', 'spread': '10.6', 'groupId': 'BG003'}, {'value': '56.4', 'spread': '5.8', 'groupId': 'BG004'}, {'value': '57.3', 'spread': '5.8', 'groupId': 'BG005'}, {'value': '54.4', 'spread': '7.7', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '43', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-06', 'studyFirstSubmitDate': '2011-01-06', 'resultsFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2011-01-06', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-06', 'studyFirstPostDateStruct': {'date': '2011-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline (Day 1) up to 14 days after last dose of study treatment (up to 28 days)', '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 14 days after last dose that were absent before treatment or that worsened relative to pre-treatment state.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) On Day 1', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours (hrs) post morning dose on Day 1 (fasted condition)'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) On Day 6', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 1', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax) on Day 6', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8 hours post-dose on Day 6 (fed condition)'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) on Day 1', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 (fasted condition)', 'description': 'AUCtau is the area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau), here dosing interval is 24 hours.'}, {'measure': 'Maximum Observed Plasma Concentration at Steady State (Cmax, ss) On Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax, ss) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)'}, {'measure': 'Area Under the Curve From Time Zero to End of Dosing Interval at Steady State (AUCtau, ss) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'description': 'AUCtau, ss = Area under the plasma concentration versus time curve from time zero (pre-dose) to the end of the dosing interval (tau) at steady state, here dosing interval is 24 hours.'}, {'measure': 'Plasma Decay Half-Life (t1/2) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24, 36, 48 hours post morning dose on Day 14 (fasted condition)', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Minimum Observed Plasma Trough Concentration at Steady State (Cmin, ss) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16 hours post morning dose on Day 14 (fasted condition)'}, {'measure': 'Percentage of Unchanged Drug Excreted in the Urine Over Dosing Interval (Ae[%]) on Day 14', 'timeFrame': '0 hour (pre-dose) through 24 hours post-dose on Day 14', 'description': 'Percentage of drug excreted unchanged in urine calculated as overall amount of unchanged drug excreted in the urine over the dosing interval (24 hours) divided by total daily dose multiplied by 100.'}, {'measure': 'Apparent Oral Clearance (CL/F) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', 'description': 'Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.'}, {'measure': 'Apparent Volume of Distribution (Vz/F) on Day 14', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 14 (fasted condition)', '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.'}, {'measure': 'Observed Accumulation Ratio for AUCtau (Rac)', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)', 'description': 'Accumulation ratio for AUCtau (Rac) was calculated as area under the curve from time zero to end of dosing interval (AUCtau) on Day 14 divided by area under the curve from time zero to end of dosing interval (AUCtau) on Day 1. Dosing interval = 24 hours.'}, {'measure': 'Observed Accumulation Ratio for Cmax (Rac, Cmax)', 'timeFrame': '0 (pre-dose), 0.5, 1.5, 3, 5, 8, 12, 16, 24 hours post morning dose on Day 1 and Day 14 (fasted condition)', 'description': 'Accumulation ratio for Cmax (Rac, Cmax) was calculated as maximum observed plasma concentration (Cmax) on Day 14 divided by maximum observed plasma concentration (Cmax) on Day 1.'}, {'measure': 'Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.'}, {'measure': 'Percent Change From Baseline in Glucose Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 14', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma glucose concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.'}], 'secondaryOutcomes': [{'measure': 'Percent Change From Baseline in Insulin Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma insulin concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.'}, {'measure': 'Percent Change From Baseline in C-peptide Area Under the Curve From Time 2 to 6 Hours (AUC [2-6]) After a Mixed Meal Tolerance Test (MMTT) at Day 1 and 14', 'timeFrame': '-46, -45.75, -45.5, -45, -44.5, -44, -43, -42 hrs pre-dose on Day -1; 2, 2.25, 2.5, 3, 3.5, 4, 5, 6 hrs post-dose on Day 1 and 14 (fasted condition)', 'description': 'Percent change from baseline in area under the plasma C-peptide concentration-time curve as determined by standardized MMTT. Linear trapezoidal method was used to compute AUC. Baseline value was the AUC (2-6) calculated on Day -1.'}, {'measure': 'Change From Baseline in Average Plasma Glucose at Day 1, 6, 14', 'timeFrame': '-46, -44, -42, -40, -38, -36, -30, -27 hrs pre-dose on Day -1; 2, 6, 8, 10, 12,18,21 hrs post-dose on Day 1, 6 and 14; additional 0 hr (pre-dose) on Day 6 and 4 hr post-dose on Day 1 and 14', 'description': 'Glucometer testing performed by finger-stick at 8 time points per day to measure glucose levels. Average plasma glucose was calculated as area under the plasma glucose concentration-time curve from 0 to 24 hours (AUC \\[0-24\\]) divided by 24.'}, {'measure': 'Change From Baseline in Fasting Plasma Glucose at Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15', 'timeFrame': 'Baseline (Pre-dose on Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15'}, {'measure': 'Change From Baseline in Triglyceride (TG) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.'}, {'measure': 'Change From Baseline in Total Cholesterol (TC) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.'}, {'measure': 'Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.'}, {'measure': 'Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) Level at Day 3, 6, 10, 14, 16 and Follow-up', 'timeFrame': 'Baseline (Day -2), Day 3, 6, 10, 14, 16 and Follow-up (7 to 14 days after last dose of study medication)', 'description': 'Blood sample for lipid biomarker was taken following 12-hours fasting. Baseline value was collected on Day -2 for lipids.'}, {'measure': 'Change From Baseline in Lactate Level at Day 6 and 14', 'timeFrame': 'Baseline (Day 1), Day 6 and 14', 'description': 'Baseline value was collected at 0 hour on Day 1 for lactate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics PK Pharmacodynamics PD T2DM Phase 1 Type 2 diabetes mellitus safety and tolerability'], 'conditions': ['Diabetes Mellitus, Type 2', 'NIDDM']}, 'referencesModule': {'references': [{'pmid': '25142735', 'type': 'DERIVED', 'citation': 'Sharma R, Litchfield J, Atkinson K, Eng H, Amin NB, Denney WS, Pettersen JC, Goosen TC, Di L, Lee E, Pfefferkorn JA, Dalvie DK, Kalgutkar AS. Metabolites in safety testing assessment in early clinical development: a case study with a glucokinase activator. Drug Metab Dispos. 2014 Nov;42(11):1926-39. doi: 10.1124/dmd.114.060087. Epub 2014 Aug 20.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1621003&StudyName=Multiple%20Dose%20Study%20Of%20PF-04937319%20In%20Patients%20With%20Type%202%20Diabetes', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-04937319 following multiple (14 days) escalating oral doses in patients with type 2 diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus who are taking metformin only.\n* Treatment should be stable, where this is defined as no change in the treatment, including dose, over the past 2 months. Regimens may include once daily and twice daily dosing only.\n* Male and/or female patients (females will be women of non childbearing potential)\n* Body Mass Index (BMI) of 18.5 to 45.0 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* HbA1c between 7.0% and 10.0%.\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). Patients who have chronic conditions other than T2DM (for example, hypercholesterolemia or hypertension) but are controlled by either diet or stable (for the last 2 months) doses of medications may be included as well (for example, a subject with hypercholesterolemia on appropriate treatment is eligible).\n* Evidence or history of diabetic complications with significant end organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance less than 60 mL/min\n* Any condition possibly affecting drug absorption (eg, gastrectomy)\n* History of stroke or transient ischemic attack or myocardial infarction within the past 6 months\n* History of coronary artery bypass graft or stent implantation.\n* Clinically significant peripheral vascular disease (eg, manifested by claudication).\n* Any history or clinical evidence of congestive heart failure, NYHA Classes II to IV.\n* One or more self reported significant/severe/requiring treatment episodes of hypoglycemia within the last 3 months, or two or more self reported significant/severe/requiring treatment episodes of hypoglycaemia within the last 6 months.\n* Current history of angina/unstable angina.\n* Milk or soy allergy'}, 'identificationModule': {'nctId': 'NCT01272804', 'briefTitle': 'Multiple Dose Study Of PF-04937319 In Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Placebo-controlled Trial To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Escalating Oral Doses Of Pf-04937319 In Adult Patients With Type 2 Diabetes Mellitus (t2dm)', 'orgStudyIdInfo': {'id': 'B1621003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04937319', 'interventionNames': ['Drug: PF-04937319']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04937319', 'type': 'DRUG', 'description': 'Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.', 'armGroupLabels': ['PF-04937319']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33169', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Elite Research Institute', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Research Associates', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'MRA Clinical Research', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '45212', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology Unit', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}