Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT04628793
Status:
COMPLETED
Last Update Posted:
2024-02-21
First Post:
2020-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}}, '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': {'timeFrame': 'From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)', 'description': 'SAEs and nonserious AEs were recorded on the Case Report Form. SAEs were also reported on the Clinical Trial SAE report form to Pfizer Safety within 24h of awareness. The same event may appear as both an AE and SAE. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs/AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 6, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Atrioventricular block first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Noninfective gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Vaccination complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'SARS-CoV-2 test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 6, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort'}, {'id': 'OG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'title': 'All-causality TEAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}, {'title': 'Treatment-related TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort'}, {'id': 'OG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable laboratory values were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort'}, {'id': 'OG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'title': 'Standing diastolic BP increase >=20mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Standing diastolic BP decrease >=20mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Standing systolic BP increase >=30mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Standing systolic BP decrease >=30mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}, {'title': 'Supine diastolic BP increase >=20mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Supine diastolic BP decrease >=20mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Supine systolic BP increase >=30mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'Supine systolic BP decrease >=30mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of \\>=20mmHg, standing systolic BP increase and decrease from BL of \\>=30mmHg, supine diastolic BP increase and decrease from BL of \\>=20mmHg, supine systolic BP increase and decrease from BL of \\>=30mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable vital signs data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort'}, {'id': 'OG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'title': 'PR interval %change >=25/50% (BL >200msec and >=25% increase or BL <=200msec and >=50% increase)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QRS interval %change >=50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QTcF change >=30 and <=60msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}, {'title': 'QTcF change >60msec', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL \\>200msec and max \\>=25% increase from BL, or BL \\<=200msec and max \\>=50% increase from BL, QRS interval percent change from BL \\>=50%, QTcF change from BL \\>=30 and \\<=60msec, or change from BL \\>60msec.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention. Participants with evaluable ECG data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Pooled Placebo', 'description': 'All participants who received placebo in any period of any cohort'}, {'id': 'OG001', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG002', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG003', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG004', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG005', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG006', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG007', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG008', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG009', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis set included all participants randomly assigned to study intervention and who received a dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Maximum Observed Concentration (Cmax) of PF-07258669', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG001', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG002', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG003', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG004', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG005', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG006', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG007', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG008', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8439', 'spread': '13', 'groupId': 'OG000'}, {'value': '3.053', 'spread': '35', 'groupId': 'OG001'}, {'value': '10.72', 'spread': '40', 'groupId': 'OG002'}, {'value': '26.48', 'spread': '35', 'groupId': 'OG003'}, {'value': '53.30', 'spread': '24', 'groupId': 'OG004'}, {'value': '188.1', 'spread': '3', 'groupId': 'OG005'}, {'value': '573.4', 'spread': '45', 'groupId': 'OG006'}, {'value': '1173', 'spread': '41', 'groupId': 'OG007'}, {'value': '1604', 'spread': '64', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'Cmax is the maximum observed plasma concentration.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG001', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG002', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG003', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG004', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG005', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG006', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG007', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG008', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.421', 'spread': '13', 'groupId': 'OG000'}, {'value': '7.826', 'spread': '30', 'groupId': 'OG001'}, {'value': '27.83', 'spread': '27', 'groupId': 'OG002'}, {'value': '75.84', 'spread': '29', 'groupId': 'OG003'}, {'value': '182.2', 'spread': '16', 'groupId': 'OG004'}, {'value': '584.8', 'spread': '11', 'groupId': 'OG005'}, {'value': '2148', 'spread': '12', 'groupId': 'OG006'}, {'value': '4013', 'spread': '21', 'groupId': 'OG007'}, {'value': '5764', 'spread': '34', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'SECONDARY', 'title': 'Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG001', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG002', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG003', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG004', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG005', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG006', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG007', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG008', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.659', 'spread': '14', 'groupId': 'OG000'}, {'value': '8.252', 'spread': '28', 'groupId': 'OG001'}, {'value': '28.55', 'spread': '28', 'groupId': 'OG002'}, {'value': '76.63', 'spread': '28', 'groupId': 'OG003'}, {'value': '183.0', 'spread': '15', 'groupId': 'OG004'}, {'value': '586.9', 'spread': '11', 'groupId': 'OG005'}, {'value': '2156', 'spread': '12', 'groupId': 'OG006'}, {'value': '4033', 'spread': '21', 'groupId': 'OG007'}, {'value': '6036', 'spread': '32', 'groupId': 'OG008'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'AUCinf is the area under the plasma concentration time profile from time 0 extrapolated to infinite time.', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'SECONDARY', 'title': 'Time for Cmax (Tmax) of PF-07258669', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG001', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG002', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG003', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG004', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG005', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG006', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG007', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG008', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '1.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '1.50'}, {'value': '1.00', 'groupId': 'OG001', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.750', 'groupId': 'OG002', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '0.750', 'groupId': 'OG003', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG004', 'lowerLimit': '0.500', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG006', 'lowerLimit': '0.500', 'upperLimit': '1.50'}, {'value': '1.25', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '2.00'}, {'value': '1.00', 'groupId': 'OG008', 'lowerLimit': '0.500', 'upperLimit': '1.50'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'Tmax is the time for Cmax.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated.'}, {'type': 'SECONDARY', 'title': 'Terminal Half-life (t1/2) of PF-07258669', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'PF-07258669 0.1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.1mg'}, {'id': 'OG001', 'title': 'PF-07258669 0.3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 0.3mg'}, {'id': 'OG002', 'title': 'PF-07258669 1mg', 'description': 'Participants in Cohort 1 who received PF-07258669 1mg'}, {'id': 'OG003', 'title': 'PF-07258669 3mg', 'description': 'Participants in Cohort 1 who received PF-07258669 3mg'}, {'id': 'OG004', 'title': 'PF-07258669 10mg', 'description': 'Participants in Cohort 2 who received PF-07258669 10mg'}, {'id': 'OG005', 'title': 'PF-07258669 30mg', 'description': 'Participants in Cohort 2 who received PF-07258669 30mg'}, {'id': 'OG006', 'title': 'PF-07258669 100mg', 'description': 'Participants in Cohort 2 who received PF-07258669 100mg'}, {'id': 'OG007', 'title': 'PF-07258669 200mg', 'description': 'Participants in Cohort 2 who received PF-07258669 200mg'}, {'id': 'OG008', 'title': 'PF-07258669 300mg', 'description': 'Participants in Cohort 3 who received PF-07258669 300mg'}], 'classes': [{'categories': [{'measurements': [{'value': '2.508', 'spread': '0.92446', 'groupId': 'OG000'}, {'value': '3.828', 'spread': '0.92253', 'groupId': 'OG001'}, {'value': '4.572', 'spread': '0.93360', 'groupId': 'OG002'}, {'value': '5.013', 'spread': '0.52812', 'groupId': 'OG003'}, {'value': '5.558', 'spread': '0.78987', 'groupId': 'OG004'}, {'value': '6.698', 'spread': '1.6508', 'groupId': 'OG005'}, {'value': '6.415', 'spread': '1.5912', 'groupId': 'OG006'}, {'value': '6.880', 'spread': '1.9697', 'groupId': 'OG007'}, {'value': '12.99', 'spread': '10.045', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 't1/2 is the terminal half-life.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants randomly assigned to study intervention and who received a dose of study intervention, and had at least 1 of the PK parameters of interest calculated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'Participants in Cohort 1 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo at 0.1mg, 0.3mg, 1mg, and 3mg on Day 1 in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo.'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'Participants in Cohort 2 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo on Day 1 at 10mg, 30mg, 100mg, and 200mg in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo.'}, {'id': 'FG002', 'title': 'Cohort 3', 'description': 'Participants in Cohort 3 underwent 1 treatment period and received 300 mg PF-07258669 or placebo in a 3:1 manner on Day 1 in Period 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '8 participants were planned for all periods in Cohort 1. However, additional participants were enrolled if \\<8 participants were enrolled in Period 1 and/or to replace participants who dropped out during the study for reasons not related to safety or tolerability. These additional participants may have entered later periods directly.', 'groupId': 'FG000', 'numSubjects': '10'}, {'comment': '8 participants were planned for all periods in Cohort 2. However, additional participants were enrolled if \\<8 participants were enrolled in Period 1 and/or to replace participants who dropped out during the study for reasons not related to safety or tolerability. These additional participants may have entered later periods directly.', 'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Period 1', 'achievements': [{'comment': '2 participants received placebo and 5 received PF-07258669 0.1mg on Period 1 Day 1.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '2 participants received placebo and 6 received PF-07258669 10mg on Period 1 Day 1.', 'groupId': 'FG001', 'numSubjects': '8'}, {'comment': '2 participants received placebo and 6 received PF-07258669 300mg on Period 1 Day 1.', 'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Period 2', 'achievements': [{'comment': '2 participants received placebo and 5 received PF-07258669 0.3mg on Period 2 Day 1.', 'groupId': 'FG000', 'numSubjects': '7'}, {'comment': '2 participants received placebo and 5 received PF-07258669 30mg on Period 2 Day 1.', 'groupId': 'FG001', 'numSubjects': '7'}, {'comment': 'No participant entered Period 2.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Period 3', 'achievements': [{'comment': '2 participants received placebo and 6 received PF-07258669 1mg on Period 3 Day 1.', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '2 participants received placebo and 6 received PF-07258669 100mg on Period 3 Day 1.', 'groupId': 'FG001', 'numSubjects': '8'}, {'comment': 'No participant entered Period 3.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Period 4', 'achievements': [{'comment': '2 participants received placebo and 6 received PF-07258669 3mg on Period 4 Day 1.', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '2 participant received placebo and 6 received PF-07258669 200mg on Period 4 Day 1.', 'groupId': 'FG001', 'numSubjects': '8'}, {'comment': 'No participant entered Period 4.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'comment': 'Completion of the entire study including the follow-up phase', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '1 participant completed double blind treatment and discontinued during follow-up phase due to lost to follow-up.', 'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Participants in Cohort 1 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo at 0.1mg, 0.3mg, 1mg, and 3mg on Day 1 in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo.'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'Participants in Cohort 2 underwent 4 treatment periods receiving up to 3 doses of PF-07258669 and up to 1 dose of placebo on Day 1 at 10mg, 30mg, 100mg, and 200mg in Periods 1-4 respectively. There was a washout interval of at least 7 days after each period. At each dose level, participants were assigned in an approximately 3:1 manner to receive PF-07258669 and placebo.'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'Participants in Cohort 3 underwent 1 treatment period and received 300 mg PF-07258669 or placebo in a 3:1 manner on Day 1 in Period 1.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.5', 'groupId': 'BG000', 'lowerLimit': '23.0', 'upperLimit': '54.0'}, {'value': '42.0', 'groupId': 'BG001', 'lowerLimit': '34.0', 'upperLimit': '52.0'}, {'value': '32.5', 'groupId': 'BG002', 'lowerLimit': '20.0', 'upperLimit': '56.0'}, {'value': '40.0', 'groupId': 'BG003', 'lowerLimit': '20.0', 'upperLimit': '56.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '18-44 Years', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}, {'title': '45-60 Years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All randomized participants who received a dose of study intervention'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-09', 'size': 5956933, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-03T15:25', 'hasProtocol': True}, {'date': '2021-02-01', 'size': 3528603, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-08-03T15:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2020-11-09', 'resultsFirstSubmitDate': '2022-08-03', 'studyFirstSubmitQcDate': '2020-11-09', 'lastUpdatePostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-21', 'studyFirstPostDateStruct': {'date': '2020-11-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'From first dose of study intervention (Day 1) to telephone Follow Up (28-35 days after lase dose of study intervention) (approximately up to 20 weeks)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a patient or clinical study subject, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE (SAE) was defined as any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect; or other serious situations such as important medical events. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE.'}, {'measure': 'Number of Participants With Clinical Laboratory Abnormalities (Without Regard to Baseline [BL] Abnormality)', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': "Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion."}, {'measure': 'Number of Participants With Change From BL in Vital Signs Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'Abnormality in change from BL in vital signs included: standing diastolic blood pressure (BP) increase and decrease from BL of \\>=20mmHg, standing systolic BP increase and decrease from BL of \\>=30mmHg, supine diastolic BP increase and decrease from BL of \\>=20mmHg, supine systolic BP increase and decrease from BL of \\>=30mmHg.'}, {'measure': 'Number of Participants With Change From BL in Electrocardiogram (ECG) Data Meeting the Pre-defined Categorical Summarization Criteria', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'ECG assessments inlcuded PR, QT, QTcF intervals and QRS complex. ECG abnormalities in change from BL included: PR interval BL \\>200msec and max \\>=25% increase from BL, or BL \\<=200msec and max \\>=50% increase from BL, QRS interval percent change from BL \\>=50%, QTcF change from BL \\>=30 and \\<=60msec, or change from BL \\>60msec.'}, {'measure': 'Number of Participants With Clinically-significant Change From BL in Neurological Examination Findings', 'timeFrame': 'From BL to onsite Follow Up visit (up to 9 days after last dose of study intervention) (approximately up to 17 weeks)', 'description': 'The neurological exam consisted of assessment of higher cortical function, the cranial nerves, motor function, deep tendon reflexes, sensory exam, and coordination and gait, to the extent needed to assess the participant for any potential changes in neurological status, as determined by the investigator (or designee).'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of PF-07258669', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'Cmax is the maximum observed plasma concentration.'}, {'measure': 'Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07258669', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'AUClast is the area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration.'}, {'measure': 'Area Under the Plasma Concentration Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-07258669', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'AUCinf is the area under the plasma concentration time profile from time 0 extrapolated to infinite time.'}, {'measure': 'Time for Cmax (Tmax) of PF-07258669', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 'Tmax is the time for Cmax.'}, {'measure': 'Terminal Half-life (t1/2) of PF-07258669', 'timeFrame': 'At 0 (prior to dose), 0.17, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 16, 24, 36, and 48 hours post dose on Day 1 in Periods 1 to 4', 'description': 't1/2 is the terminal half-life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PF-07258669', 'first in human', 'melanocortin-4 receptor', 'MC4R', 'healthy participants', 'safety', 'tolerability', 'pharmacokinetics'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C4541001', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will be the first time PF-07258669 is administered to humans. The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-07258669 following administration of single oral doses to healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female participants of non-child bearing potential and male participants and who are overtly healthy as determined by medical evaluation including medical history, physical examination, neurological examination, laboratory tests, and cardiac monitoring.\n* Participants who are willing to avoid direct sunlight exposure or any high intensity ultraviolet light exposure from admission to the follow-up contact and to apply sunscreen/lotion with a high sun protection factor, as appropriate.\n* BMI of 17.5 to 30.5 kg/m2; and a total body weight \\>50 kg (110 lb).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing), as well as presence of lipid panel abnormalities (eg, hypercholesterolemia, hypertriglyceridemia).\n* Evidence of history of orthostatic hypotension or symptomatic bradycardia.\n* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.\n* Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).\n* Current findings or documented past history of blood pressure values \\<90 mmHg systolic or \\<50 mmHg diastolic.\n* Any lipid panel parameter (ie, total cholesterol, triglycerides, HDL, and/or LDL) ≥1.25× ULN.'}, 'identificationModule': {'nctId': 'NCT04628793', 'briefTitle': 'A Study of Single Ascending Doses of PF-07258669 in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO-CONTROLLED, FIRST-IN-HUMAN STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF SINGLE ASCENDING ORAL DOSES OF PF-07258669 ADMINISTERED TO HEALTHY ADULT PARTICIPANTS', 'orgStudyIdInfo': {'id': 'C4541001'}, 'secondaryIdInfos': [{'id': '2020-004280-42', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.', 'interventionNames': ['Drug: PF-07258669', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.', 'interventionNames': ['Drug: PF-07258669', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Single dose administration of PF-07258669 and placebo; Within a cohort, participants will receive 3 doses of PF-07258669 and 1 dose of placebo.', 'interventionNames': ['Drug: PF-07258669', 'Drug: Placebo']}], 'interventions': [{'name': 'PF-07258669', 'type': 'DRUG', 'description': 'PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo will be prepared as an oral solution and/or suspension given in each cohort', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'QPS-MRA, LLC-Main Office', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}