Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2026-06-04 @ 6:53 PM
Study NCT ID:
NCT03445169
Status:
COMPLETED
Last Update Posted:
2020-11-09
First Post:
2018-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000720612', 'term': 'belzutifan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2018-05-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-05', 'studyFirstSubmitDate': '2018-02-20', 'studyFirstSubmitQcDate': '2018-02-20', 'lastUpdatePostDateStruct': {'date': '2020-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentrations of belzutifan assessed in both the fasting and non-fasting conditions and compared', 'timeFrame': '9 days in each of the fasting and non-fasting arms', 'description': 'Blood samples to assess concentrations of belzutifan will be collected throughout the sampling time frame'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This Phase 1, single-dose study will be conducted in adult male and female subjects (N = 16) who are in general good health and selected for participation in the study according to the selection criteria. This study will assess the effect of food on the pharmacokinetics of belzutifan Tablets. The study will consist of two periods and will be conducted in a crossover fashion.', 'detailedDescription': 'Subjects will be randomized in equal numbers to two sequences of meal conditions (fasting and non-fasting). Serial blood samples will be collected after dose administration in each period. Subjects will be confined at the clinical research for a portion of each period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female or vasectomized male;\n* If of childbearing potential, willing to practice methods of birth control;\n* If of childbearing potential, must be non-pregnant and non-lactating and have a negative serum pregnancy test result prior to enrollment into the trial;\n* Has a body mass index (BMI) between 19 and 32 kg/m2; Willing and able to give written informed consent for study participation and provide consent for access to medical data;\n* Willing and able to cooperate with all aspects of the protocol.\n\nExclusion Criteria:\n\n* Any vaccination within 30 days before start of this study and throughout the study;\n* Abnormal blood pressure or pulse rate;\n* Abnormal screening electrocardiogram (ECG);\n* Receipt of any investigational agent within 30 days;\n* A positive history of drug abuse or a positive test result for drug(s) of abuse;\n* Female subjects who are planning a pregnancy or are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT03445169', 'briefTitle': 'A Food Effect Study in Healthy Volunteers With Belzutifan (PT2977, MK-6482) Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'A Single-Dose, Open-Label, Randomized, Food Effect Study in Healthy Volunteers With PT2977 Tablets', 'orgStudyIdInfo': {'id': '6482-002'}, 'secondaryIdInfos': [{'id': 'PT2977-103', 'type': 'OTHER', 'domain': 'Pelaton Study ID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasting', 'description': 'Belzutifan tablets taken after fasting', 'interventionNames': ['Drug: Belzutifan']}, {'type': 'EXPERIMENTAL', 'label': 'Non-Fasting', 'description': 'Belzutifan taken after eating a high calorie meal', 'interventionNames': ['Drug: Belzutifan']}], 'interventions': [{'name': 'Belzutifan', 'type': 'DRUG', 'otherNames': ['MK-6482,', 'PT2977'], 'description': 'Belzutifan Tablets', 'armGroupLabels': ['Fasting', 'Non-Fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53095', 'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Spaulding Clinical', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}