Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06153758
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000731016', 'term': 'danuglipron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '4-Part'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2023-11-22', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parts A, C and D only: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'Parts A, C and D only: Maximum observed concentration (Cmax) for danuglipron in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'Parts A, C and D only: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'Part B only: Dose normalized area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf,dn), as data permit, for danuglipron in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'Part B only: Dose normalized maximum observed concentration (Cmax,dn) for danuglipron in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'Part B only: Dose normalized area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast,dn) for danuglipron (only if AUCinf,dn is not reportable) in the fasted state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}], 'secondaryOutcomes': [{'measure': 'All Parts: Number of Participants reporting Treatment Emergent Adverse Events', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'All Parts: Number of Participants reporting Clinically Significant ECG Abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'All Parts: Number of Participants reporting Clinically Significant Vital Sign Abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'All Parts: Number of participants reporting clinically significant clinical laboratory abnormalities', 'timeFrame': 'From baseline up to 28-35 days post last dose taken'}, {'measure': 'All Parts: Area under the concentration-time curve from time zero extrapolated to infinite time (AUCinf), as data permit, for danuglipron in the fed state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'All Parts: Maximum observed concentration (Cmax) for danuglipron in the fed state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}, {'measure': 'All Parts: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for danuglipron (only if AUCinf is not reportable) in the fed state', 'timeFrame': 'Predose to 48 hours post danuglipron administration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Healthy Subjects']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=C3421074', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to learn how different forms of a study medication called danuglipron are taken into the blood in healthy adults, following single dose administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or older and overtly healthy\n* Body mass Index (BMI) between 16-32 kg/m2; and a total body weight \\>50 kg (110 lb)\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant medical conditions or laboratory abnormality\n* Any condition possibly affecting drug absorption\n* Known intolerance/hypersensitivity to a GLP-1 R agonist\n* Use of prescription drugs, nonprescription drugs, dietary supplements or herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of danuglipron in each part of the study.'}, 'identificationModule': {'nctId': 'NCT06153758', 'briefTitle': 'Study to Learn How Different Forms of The Study Medicine Called Danuglipron Are Taken up Into the Blood In Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, 4-Part, Open-Label, Randomized Study With A 5-Period, 4 Sequence, Crossover Design to Compare the Single Dose Pharmacokinetics Between Immediate and Modified Release Formulations of Danuglipron Administered Orally to Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'C3421074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A', 'description': 'Participants will receive a single oral dose of danuglipron on Day 1 of each period', 'interventionNames': ['Drug: Danuglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Part B', 'description': 'Participants will receive a single oral dose of danuglipron on Day 1 of each period', 'interventionNames': ['Drug: Danuglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Part C', 'description': 'Participants will receive a single oral dose of danuglipron on Day 1 of each period', 'interventionNames': ['Drug: Danuglipron']}, {'type': 'EXPERIMENTAL', 'label': 'Part D', 'description': 'Participants will receive a single oral dose of danuglipron on Day 1 of each period', 'interventionNames': ['Drug: Danuglipron']}], 'interventions': [{'name': 'Danuglipron', 'type': 'DRUG', 'otherNames': ['PF-06882961'], 'description': 'Danuglipron oral tablets', 'armGroupLabels': ['Part A', 'Part B', 'Part C', 'Part D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials, LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], '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'}}}}