Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2025-12-26 @ 5:00 AM
Study NCT ID:
NCT06122194
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2023-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers
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 Clinical Trials.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 publication 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 start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)', 'description': 'Safety population included all participants randomly assigned to study treatment, who took at least 1 dose of study treatment. Participants were analyzed according to the product they actually received.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 3, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Lip dry', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Vessel puncture site bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Polyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 11, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 12, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 11, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax) of PF-07817883', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2308', 'spread': '39', 'groupId': 'OG000'}, {'value': '2579', 'spread': '28', 'groupId': 'OG001'}, {'value': '4266', 'spread': '40', 'groupId': 'OG002'}, {'value': '3566', 'spread': '34', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '112.15', 'ciLowerLimit': '93.01', 'ciUpperLimit': '135.22', 'groupDescription': 'Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90 percent (%) confidence intervals (CIs) were expressed as percentages.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '187.37', 'ciLowerLimit': '155.79', 'ciUpperLimit': '225.35', 'groupDescription': 'Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '153.61', 'ciLowerLimit': '127.40', 'ciUpperLimit': '185.21', 'groupDescription': 'Natural log transformed Cmax for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '17660', 'spread': '35', 'groupId': 'OG000'}, {'value': '18200', 'spread': '22', 'groupId': 'OG001'}, {'value': '21040', 'spread': '36', 'groupId': 'OG002'}, {'value': '21510', 'spread': '33', 'groupId': 'OG003'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.59', 'ciLowerLimit': '91.09', 'ciUpperLimit': '115.54', 'groupDescription': 'Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '125.07', 'ciLowerLimit': '110.81', 'ciUpperLimit': '141.17', 'groupDescription': 'Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Ratio of Adjusted Geometric Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '121.75', 'ciLowerLimit': '108.65', 'ciUpperLimit': '136.43', 'groupDescription': 'Natural log transformed AUCinf for PF-07817883 were analyzed using a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect in Periods 1 to 4. The ratio (Test/Reference) and 90% CIs were expressed as percentages.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period', 'unitOfMeasure': 'nanogram*hour per milliliter (ng*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK parameter analysis population was defined as all participants randomized and treated who had at least 1 of the PK parameters of interest in at least 1 treatment period. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': 'Laboratory parameters included hematology (eosinophils/leukocytes \\[%\\] greater than \\[\\>\\] 1.2\\*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal \\[\\>=\\] to 1).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received. Here, "Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormality in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': 'Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\\<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (\\>=) 30 mmHg increase, change from baseline \\>=30 mmHg decrease; DBP: value \\<50 mmHg, change from baseline \\>=20 mmHg increase, change from baseline \\>=20 mmHg decrease; PR: value \\<40 beats per minute (bpm), value greater than (\\>) 120 bpm.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A: PF-07817883 300 mg Reference Formulation', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of reference formulation on Day 1 of any period.'}, {'id': 'OG001', 'title': 'Treatment B: PF-07817883 300 mg Test Formulation 1', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 1 on Day 1 of any period.'}, {'id': 'OG002', 'title': 'Treatment C: PF-07817883 300 mg Test Formulation 2', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 2 on Day 1 of any period.'}, {'id': 'OG003', 'title': 'Treatment D: PF-07817883 300 mg Test Formulation 3', 'description': 'Participants received PF-07817883 300 mg, tablet, orally as single dose of test formulation 3 on Day 1 of any period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': "Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (\\>=300 millisecond \\[msec\\], percent \\[%\\] change from baseline \\>=25 to 50%), QRS duration (\\>=140 msec, %change from baseline \\>=50%), corrected QT interval using Fridericia's formula (QTcF) (\\>500 msec, %change from baseline \\>60 msec, 450 msec\\<value less than equal to \\[\\<=\\] 480 msec, 480 msec\\<value\\<=500 msec, 30 msec\\<=change\\<=60 msec).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 1: A Then B Then C Then D', 'description': 'Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 milligram (mg) tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'FG001', 'title': 'Treatment Sequence 2: B Then D Then A Then C', 'description': 'Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'FG002', 'title': 'Treatment Sequence 3: C Then A Then D Then B', 'description': 'Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'FG003', 'title': 'Treatment Sequence 4: D Then C Then B Then A', 'description': 'Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}], 'periods': [{'title': 'Treatment Period 1 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 3 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 4 (3 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'A total of 12 participants were enrolled and randomized in this study to 1 of the 4 study treatment sequences.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence 1: A Then B Then C Then D', 'description': 'Participants were randomized to receive a single oral dose of treatment A on Day 1 of Period 1; followed by a single oral dose of treatment B on Day 1 of Period 2; followed by a single oral dose of treatment C on Day 1 of Period 3; followed by a single oral dose of treatment D on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'BG001', 'title': 'Treatment Sequence 2: B Then D Then A Then C', 'description': 'Participants were randomized to receive a single oral dose of treatment B on Day 1 of Period 1; followed by a single oral dose of treatment D on Day 1 of Period 2; followed by a single oral dose of treatment A on Day 1 of Period 3; followed by a single oral dose of treatment C on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'BG002', 'title': 'Treatment Sequence 3: C Then A Then D Then B', 'description': 'Participants were randomized to receive a single oral dose of treatment C on Day 1 of Period 1; followed by a single oral dose of treatment A on Day 1 of Period 2; followed by a single oral dose of treatment D on Day 1 of Period 3; followed by a single oral dose of treatment B on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'BG003', 'title': 'Treatment Sequence 4: D Then C Then B Then A', 'description': 'Participants were randomized to receive a single oral dose of treatment D on Day 1 of Period 1; followed by a single oral dose of treatment C on Day 1 of Period 2; followed by a single oral dose of treatment B on Day 1 of Period 3; followed by a single oral dose of treatment A on Day 1 of Period 4. Between 2 doses of consecutive period there was a gap of at least 48 hours (2 days). A=PF-07817883 300 mg tablet reference formulation, B=PF-07817883 300 mg tablet test formulation 1, C=PF-07817883 300 mg tablet test formulation 2 and D=PF-07817883 300 mg tablet test formulation 3. All formulations were administered under fasting condition.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean (SD)', 'categories': [{'measurements': [{'value': '58.7', 'spread': '4.93', 'groupId': 'BG000'}, {'value': '34.7', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '41.3', 'spread': '18.15', 'groupId': 'BG002'}, {'value': '51.0', 'spread': '21.28', 'groupId': 'BG003'}, {'value': '46.4', 'spread': '15.48', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis set included all participants randomly assigned to study treatment and who took at least 1 dose of study treatment in at least one treatment period. Participants were analyzed according to the product they actually received.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-24', 'size': 9873415, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-23T15:03', 'hasProtocol': True}, {'date': '2023-11-22', 'size': 1418523, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-23T15:05', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This is an open-label study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4 period 4 sequence crossover design'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-23', 'studyFirstSubmitDate': '2023-10-10', 'resultsFirstSubmitDate': '2024-12-23', 'studyFirstSubmitQcDate': '2023-11-02', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-23', 'studyFirstPostDateStruct': {'date': '2023-11-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of PF-07817883', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07817883', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post-dose on Day 1 of each treatment period'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From start of study treatment (Day 1) up to 28-35 days after last dose of study treatment (maximum up to 47 days)', 'description': 'An adverse event (AE) was any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent are events between first dose of study treatment and up to 28-35 days after last dose that were absent before treatment or that worsened relative to pretreatment state.'}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': 'Laboratory parameters included hematology (eosinophils/leukocytes \\[%\\] greater than \\[\\>\\] 1.2\\*upper limit of normal), and urinalysis (urine hemoglobin and leukocyte esterase greater than or equal \\[\\>=\\] to 1).'}, {'measure': 'Number of Participants With Clinically Significant Abnormality in Vital Signs', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': 'Vital signs included diastolic blood pressure (DBP), systolic blood pressure (SBP) and pulse rate (PR) were measured in a supine position after approximately 5 minutes of rest for the participant. Criteria for vital signs included: SBP: value less than (\\<) 90 millimeters of mercury (mmHg), change from baseline greater than or equal to (\\>=) 30 mmHg increase, change from baseline \\>=30 mmHg decrease; DBP: value \\<50 mmHg, change from baseline \\>=20 mmHg increase, change from baseline \\>=20 mmHg decrease; PR: value \\<40 beats per minute (bpm), value greater than (\\>) 120 bpm.'}, {'measure': 'Number of Participants With Clinically Significant Abnormality in Electrocardiogram (ECG)', 'timeFrame': 'From start of study treatment (Day 1) up to last dose of study treatment (maximum up to 12 days)', 'description': "Standard 12 lead ECGs were obtained with the participant in a supine position after at least 5 minutes of rest. Criteria were PR interval (\\>=300 millisecond \\[msec\\], percent \\[%\\] change from baseline \\>=25 to 50%), QRS duration (\\>=140 msec, %change from baseline \\>=50%), corrected QT interval using Fridericia's formula (QTcF) (\\>500 msec, %change from baseline \\>60 msec, 450 msec\\<value less than equal to \\[\\<=\\] 480 msec, 480 msec\\<value\\<=500 msec, 30 msec\\<=change\\<=60 msec)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5091013', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.', 'detailedDescription': 'This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.\n* BMI of 16 to 32 kg/m2; and a total body weight \\>45 kg\n* Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.\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).\n\n 1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).\n 2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.\n* Positive test result for SARS-CoV-2 infection at admission"}, 'identificationModule': {'nctId': 'NCT06122194', 'briefTitle': 'A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF PF-07817883 FOLLOWING ORAL ADMINISTRATION OF NEW FORMULATIONS RELATIVE TO THE REFERENCE FORMULATION IN HEALTHY ADULT PARTICIPANTS UNDER FASTED CONDITION', 'orgStudyIdInfo': {'id': 'C5091013'}, 'secondaryIdInfos': [{'id': '2023-506442-24-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1 formulation 1 PF-07817883', 'description': 'Single oral dose of PF-07817883 tablet under fasted condition', 'interventionNames': ['Drug: Drug: PF-07817883']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2 formulation 2 PF-07817883', 'description': 'Single oral dose of PF-07817883 tablet under fasted condition', 'interventionNames': ['Drug: Drug: PF-07817883']}, {'type': 'EXPERIMENTAL', 'label': 'Period 3 formulation 3 PF-07817883', 'description': 'Single oral dose of PF-07817883 tablet under fasted condition', 'interventionNames': ['Drug: Drug: PF-07817883']}, {'type': 'EXPERIMENTAL', 'label': 'Period 4 formulation 4 PF-07817883', 'description': 'Single oral dose of PF-07817883 tablet under fasted condition', 'interventionNames': ['Drug: Drug: PF-07817883']}], 'interventions': [{'name': 'Drug: PF-07817883', 'type': 'DRUG', 'description': 'PF-07817883 tablet', 'armGroupLabels': ['Period 1 formulation 1 PF-07817883', 'Period 2 formulation 2 PF-07817883', 'Period 3 formulation 3 PF-07817883', 'Period 4 formulation 4 PF-07817883']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-1070', 'city': 'Brussels', 'state': 'Bruxelles-capitale, Région de', 'country': 'Belgium', 'facility': 'Pfizer Clinical Research Unit - Brussels', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], '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'}}}}