Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT07015918
Status:
COMPLETED
Last Update Posted:
2025-09-10
First Post:
2025-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-03', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total recovery of radioactivity expressed as a percent of total oral radioactive dose administered.', 'timeFrame': 'From dose (Day 1) and for up to 21 days thereafter'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment emergent adverse events', 'timeFrame': 'First dose (Day 1) through 28 to 35 days after final dose (approximately 12 weeks)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Male Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C5541002', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn about how much the study medicine PF-07976016 will be taken up and processed by healthy male participants. The total number of weeks of the study is up to approximately 12 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Healthy male participants', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males, 18 to 65 years of age\n* BMI 17.5 to 32 kg/m2 and a total body weight \\>50 kg (110 lb)\n* Willing and able to comply with all study procedures\n\nExclusion Criteria:\n\n* History of irregular bowel movements or lactose intolerance\n* Any medical or psychiatric condition or laboratory abnormality or other condition that may increase the risk of study participation\n* Use of any prohibited or concomitant medication(s)\n* Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests\n* Positive urine drug test\n* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence\n* Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day\n* Previous administration of an investigational product within 30 days preceding the first dose of study medicine in this study.'}, 'identificationModule': {'nctId': 'NCT07015918', 'briefTitle': 'A Study to Understand How the Study Medicine (PF-07976016) is Processed and Eliminated in Healthy Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 1, OPEN-LABEL, 2-PERIOD, FIXED-SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM, AND EXCRETION OF [14C]PF-07976016 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-07976016 IN HEALTHY MALE PARTICIPANTS USING A [14C]-MICROTRACER APPROACH', 'orgStudyIdInfo': {'id': 'C5541002'}, 'secondaryIdInfos': [{'id': '2024-518535-11-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Participants will receive doses of PF-07976016 with and without radiolabel.', 'interventionNames': ['Drug: [14C] PF-07976016', 'Drug: PF-07976016']}], 'interventions': [{'name': '[14C] PF-07976016', 'type': 'DRUG', 'description': '\\[14C\\] PF-07976016 liquid (oral) formulation', 'armGroupLabels': ['Arm 1']}, {'name': 'PF-07976016', 'type': 'DRUG', 'description': 'PF-07976016 liquid (oral) formulation', 'armGroupLabels': ['Arm 1']}, {'name': '[14C] PF-07976016', 'type': 'DRUG', 'description': '\\[14C\\] PF-07976016 intravenous (IV) formulation', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'ICON', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], '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'}}}}