Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT05767905
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2023-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From screening up to Day 35.', 'description': 'Serious adverse events(SAE) and non-serious AEs were recorded on the case report form.', 'eventGroups': [{'id': 'EG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 5, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 4, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 2, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Eyelid pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Vessel puncture site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Nail avulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Coagulation time prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Urine odour abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}, {'term': 'Rash macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'seriousEvents': [{'term': 'Wrist fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 5, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).'}, {'id': 'OG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.'}, {'id': 'OG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.'}, {'id': 'OG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}, {'id': 'OG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '3302', 'spread': '33', 'groupId': 'OG000'}, {'value': '3375', 'spread': '29', 'groupId': 'OG001'}, {'value': '3479', 'spread': '39', 'groupId': 'OG002'}, {'value': '11220', 'spread': '48', 'groupId': 'OG003'}, {'value': '22810', 'spread': '24', 'groupId': 'OG004'}, {'value': '25690', 'spread': '35', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.49', 'ciLowerLimit': '100.55', 'ciUpperLimit': '117.05', 'groupDescription': 'Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment and Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:\n\n1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.16', 'ciLowerLimit': '98.39', 'ciUpperLimit': '114.54', 'groupDescription': 'Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '228.99', 'ciLowerLimit': '178.67', 'ciUpperLimit': '293.48', 'groupDescription': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '207.19', 'ciLowerLimit': '164.41', 'ciUpperLimit': '261.09', 'groupDescription': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.19', 'ciLowerLimit': '95.55', 'ciUpperLimit': '109.30', 'groupDescription': 'Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.', 'description': 'The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PF-06821497 PK parameters of primary interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax) for PF-06821497.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).'}, {'id': 'OG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.'}, {'id': 'OG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.'}, {'id': 'OG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}, {'id': 'OG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '862.6', 'spread': '50', 'groupId': 'OG000'}, {'value': '1023', 'spread': '35', 'groupId': 'OG001'}, {'value': '1255', 'spread': '37', 'groupId': 'OG002'}, {'value': '2699', 'spread': '31', 'groupId': 'OG003'}, {'value': '7685', 'spread': '28', 'groupId': 'OG004'}, {'value': '8905', 'spread': '7', 'groupId': 'OG005'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '145.49', 'ciLowerLimit': '121.29', 'ciUpperLimit': '174.53', 'groupDescription': 'Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '122.64', 'ciLowerLimit': '102.24', 'ciUpperLimit': '147.12', 'groupDescription': 'Part 1 PF-06821497 Form 3 250 mg Fasted was the Test treatment and Part 1 PF-06821497 Form 2 250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '284.72', 'ciLowerLimit': '226.39', 'ciUpperLimit': '358.06', 'groupDescription': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG003', 'OG005'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '327.87', 'ciLowerLimit': '256.90', 'ciUpperLimit': '418.44', 'groupDescription': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat was the Test treatment and Part 2 PF-06821497 Form 2 1250 mg Fasted was the Reference treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '118.63', 'ciLowerLimit': '96.36', 'ciUpperLimit': '146.06', 'groupDescription': 'Part 1 PF-06821497 Form 1 250 mg Fasted was the Reference treatment, and Part 1 PF-06821497 Form 2 250 mg Fasted was the Test treatment.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Mixed Model was fitted to obtain:1.Ratio of geometric means 2.90% CI of ratio of geometric means'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.', 'description': 'The Cmax was observed directly from data.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK concentration population was defined as all participants randomized and treated who had at least 1 PF-06821497 concentration in at least 1 treatment period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).'}, {'id': 'OG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.'}, {'id': 'OG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.'}, {'id': 'OG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}, {'id': 'OG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to Day 35', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants was analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).'}, {'id': 'OG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.'}, {'id': 'OG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}, {'id': 'OG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.', 'description': 'Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants randomly assigned to study intervention and who took at least one dose of study intervention.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant ECG Findings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 PF-06821497 Form 1 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 material sparing tablet (MST).'}, {'id': 'OG001', 'title': 'Part 1 PF-06821497 Form 2 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 wet granulation (WG) tablet.'}, {'id': 'OG002', 'title': 'Part 1 PF-06821497 Form 3 250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1 of each period, participants received a 250 mg dose of PF-06821497 WG tablet (larger API particle size).'}, {'id': 'OG003', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fasted', 'description': 'Following an overnight fast of at least 10 hours, and after the collection of the pre-dose PF-06821497 PK sample on Day 1, participants received a 1250 mg dose of PF-06821497 WG tablet.'}, {'id': 'OG004', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed Low-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a low-fat, low-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}, {'id': 'OG005', 'title': 'Part 2 PF-06821497 Form 2 1250 mg Fed High-fat', 'description': 'Following an overnight fast of at least 10 hours and after the collection of pre-dose PF-06821497 PK sample on Day 1, participants received a high-fat, high-calorie breakfast 30 minutes prior to a dose of PF-06821497 1250mg WG tablet'}], 'classes': [{'title': 'PR Interval, aggregate (msec), value > = 300', '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'}]}]}, {'title': 'PR Interval, aggregate (msec), %Change >= 25/50%', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'QRS Duration, aggregate (msec), value >= 140', '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'}]}]}, {'title': 'QRS Duration, aggregate (msec), %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'}]}]}, {'title': 'QT Interval, aggregate (msec), value >= 500', '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'}]}]}, {'title': 'QTcB Interval, aggregate (msec), 450 <= value < 480', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'QTcB Interval, aggregate (msec), 480 <= value < 500', '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'}]}]}, {'title': 'QTcB Interval, aggregate (msec), value >= 500', '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'}]}]}, {'title': 'QTcB Interval, aggregate (msec), 30 <= change < 60', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}, {'title': 'QTcB Interval, aggregate (msec), change >= 60', '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'}]}]}, {'title': 'QTcF Interval, aggregate (msec), 450 <= value < 480', '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'}]}]}, {'title': 'QTcF Interval, aggregate (msec), 480 <= value < 500', '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'}]}]}, {'title': 'QTcF Interval, aggregate (msec), value >= 500', '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'}]}]}, {'title': 'QTcF Interval, aggregate (msec), 30 <= change < 60', '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'}]}]}, {'title': 'QTcF Interval, aggregate (msec), change >= 60', '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': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.', 'description': 'Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1: PF-06821497 Form 1 250 mg -> PF-06821497 Form 2 250 mg -> PF-06821497 Form 3 250 mg.', 'description': 'Participants received PF-06821497 (formulation 1) 250 mg material sparing tablet (MST) on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 2) 250 mg wet granulation (WG) tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.'}, {'id': 'FG001', 'title': 'Part 1: PF-06821497 Form 2 250 mg -> PF-06821497 Form 1 250 mg -> PF-06821497 Form 3 250 mg', 'description': 'Participants received PF-06821497 (formulation 2) 250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received PF-06821497 (formulation 1) 250 mg MST tablet on Day 1 of period 2 under fasted condition. Then after a minimum of 5-day washout period, participants received PF-06821497 (formulation 3) 250 mg WG tablet (larger API particle size) on Day 1 of period 3 under fasted condition.'}, {'id': 'FG002', 'title': 'Part 2:PF-06821497 1250 mg Fasted >PF-06821497 1250 mg Fed Low-fat >PF-06821497 1250 mg Fed High-fat', 'description': 'Participants received PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 1 under fasted condition, and after a minimum of 5-day washout period, participants received a received a low-fat, low-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250 mg WG tablet on Day 1 of period 2. Then after a minimum of 5-day washout period, participants received a a high-fat, high-calorie breakfast 30 minutes prior to dosing of PF-06821497 (formulation 2) 1250mg WG tablet.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 18 participants (12 participants in Part 1 and 6 participants in Part 2) were randomized and assigned to study treatments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1', 'description': 'In Part 1, each enrolled participant participated in 3 study periods to receive 3 different treatments(Treatment A: Single 250 mg dose (1 × 250 mg) of MST tablet formulation (Formulation 1), fasted; Treatment B: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment C: Single 250 mg dose (1 × 250 mg) of WG tablet formulation (larger API particle size) (Formulation 3), fasted.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration.'}, {'id': 'BG001', 'title': 'Part 2', 'description': 'In Part 2, each enrolled participant participated in 3 study periods to receive 3 different treatments (Treatment D: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fasted; Treatment E: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, low-fat; Treatment F: Single 1250 mg dose (5 × 250 mg) of WG tablet formulation (Formulation 2), fed, high-fat.) according to the sequence determined by randomization with 5-day washouts between PF-06821497 administration.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '18 -44 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': '45 - 64 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': '>= 65 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Black or African American, White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Black or African American, White, American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The baseline analysis population included all participants enrolled in the study, and the results were presented by part.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-02', 'size': 1068230, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-04-12T17:04', 'hasProtocol': True}, {'date': '2023-03-30', 'size': 425982, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-04-12T17:04', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label Study'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2023-03-02', 'resultsFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of PF-06821497', 'timeFrame': 'Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.', 'description': 'The AUCinf was determined by AUClast + (Clast/kel), where Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is the terminal phase rate constant calculated by a linear regression of the loglinear concentration-time curve. AUClast is the area under the concentration-time curve from 0 to time of last measurable concentration'}, {'measure': 'Maximum Plasma Concentration (Cmax) for PF-06821497.', 'timeFrame': 'Days 1 (pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose), 2 and 3 in Periods 1 to 3.', 'description': 'The Cmax was observed directly from data.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAEs).', 'timeFrame': 'From screening up to Day 35', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious AE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, was considered serious.'}, {'measure': 'Number of Participants With Laboratory Abnormalities', 'timeFrame': 'From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.', 'description': 'Safety laboratory assessments included urinalysis, hematology, chemistry and other. All the safety laboratory samples were collected following at least a 4-hour fast.'}, {'measure': 'Number of Participants With Clinically Significant ECG Findings', 'timeFrame': 'From screening up to Day 3 of Period 3, and prior to early termination/discontinuation, up to 10 weeks.', 'description': 'Single 12-lead electrocardiogram or electrocardiography (ECG) readings were taken at approximately each test. All ECG assessments were made after at least a 5-minute rest in a supine position and prior to any blood draws or vital sign measurements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PF-06821497', 'Relative Bioavailability', 'Food Effect'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C2321005', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand the effect of tablet formulation and presence of food on the study medicine PF-06821497 in healthy adult participants.\n\nThe study is seeking for male and female participants who:\n\n* Are 18 years of age or more.\n* Are confirmed to be healthy after performing some medical and physical tests.\n* Weigh more than 50kgs of body weight and have a body mass index of 17 and a half kg per meter squared or more.\n\nThe study consists of two parts. In each part of the study, the selected participants will take part in 3 study periods to receive 3 different treatments which are randomly assigned. There will also be a 5-day gap between each study period. This is done so that the medicine is passed out of the body before the start of next study period.\n\nEach treatment consists of a single dose of PF-06821497. The treatments differ by tablet formulation and/or whether the medicine is to be given with food or without food conditions.\n\nHow the medicine is processed in the body will be studied after giving the medicines to the participants. This will be done by collecting blood samples after each administration. The results will be used to see the effect of tablet formulation and presence of food on the amount of PF-06821497 available in the blood of the participants.\n\nIn each part, participants will be on the study up to 10 weeks, including the screening and follow-up periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants ≥18 years of age, inclusive, at screening.\n* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.\n* BMI of ≥17.5 kg/m2; and a total body weight \\>50 kg (110 lb)\n* Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.\n* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.\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) or prior allergic reaction to any component of PF-06821497.\n* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\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 product (drug or vaccine) 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)."}, 'identificationModule': {'nctId': 'NCT05767905', 'briefTitle': 'A Study to Understand the Effect of Tablet Formulation and Food on PF-06821497 in Healthy Adult Participants.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, RANDOMIZED, OPEN-LABEL, 3-PERIOD, CROSSOVER, SINGLE-DOSE, 2-PART STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF TABLET FORMULATION AND FOOD ON THE RELATIVE BIOAVAILABILITY OF PF-06821497', 'orgStudyIdInfo': {'id': 'C2321005'}, 'secondaryIdInfos': [{'id': 'NCT05767905', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: PF-06821497 Sequence 1', 'description': 'Participants randomized to Sequence 1 will receive Treatments A, B, and C in Periods 1 through 3, respectively in the form of tablets by mouth.\n\nInterventions:\n\n* Drug: Single dose of PF-06821497 Treatment A\n* Drug: Single dose of PF-06821497 Treatment B\n* Drug: Single dose of PF-06821497 Treatment C', 'interventionNames': ['Drug: PF-06821497 Treatment A', 'Drug: PF-06821497 Treatment B', 'Drug: PF-06821497 Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: PF-06821497 Sequence 2', 'description': 'Participants randomized to Sequence 2 will receive Treatments B, A and C in Periods 1 through 3, respectively in the form of tablets by mouth.\n\nInterventions:\n\n* Drug: Single dose of PF-06821497 Treatment A\n* Drug: Single dose of PF-06821497 Treatment B\n* Drug: Single dose of PF-06821497 Treatment C', 'interventionNames': ['Drug: PF-06821497 Treatment A', 'Drug: PF-06821497 Treatment B', 'Drug: PF-06821497 Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: PF-06821497 Sequence 1', 'description': 'Participants randomized to Sequence 1 will receive Treatments D, E and F in Periods 1 through 3, respectively in the form of tablets by mouth.\n\nInterventions:\n\n* Drug: Single dose of PF-06821497 Treatment D\n* Drug: Single dose of PF-06821497 Treatment E\n* Drug: Single dose of PF-06821497 Treatment F', 'interventionNames': ['Drug: PF-06821497 Treatment D', 'Drug: PF-06821497 Treatment E', 'Drug: PF-06821497 Treatment F']}], 'interventions': [{'name': 'PF-06821497 Treatment A', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered under fasting conditions.', 'armGroupLabels': ['Part 1: PF-06821497 Sequence 1', 'Part 1: PF-06821497 Sequence 2']}, {'name': 'PF-06821497 Treatment B', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered under fasting conditions.', 'armGroupLabels': ['Part 1: PF-06821497 Sequence 1', 'Part 1: PF-06821497 Sequence 2']}, {'name': 'PF-06821497 Treatment C', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered under fasting conditions.', 'armGroupLabels': ['Part 1: PF-06821497 Sequence 1', 'Part 1: PF-06821497 Sequence 2']}, {'name': 'PF-06821497 Treatment D', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered under fasting conditions.', 'armGroupLabels': ['Part 2: PF-06821497 Sequence 1']}, {'name': 'PF-06821497 Treatment E', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered after low fat meal', 'armGroupLabels': ['Part 2: PF-06821497 Sequence 1']}, {'name': 'PF-06821497 Treatment F', 'type': 'DRUG', 'description': 'A single dose of PF-06821497 administered after high fat meal.', 'armGroupLabels': ['Part 2: PF-06821497 Sequence 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New Haven Clinical Research Unit', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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'}}}}