Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06801418
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets
Sponsor:
Organization:
Raw JSON
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BMI = weight (kg)/(height \\[m\\])\\^2.\n* Total body weight ≥ 50 kg.\n* Individuals of childbearing potential (IOCBP) and male (as assigned at birth) participants who are sexually active with IOCBP must agree to follow instructions for method(s) of contraception as included in the ICF.\n* A female (as assigned at birth) is eligible to participate if she is not pregnant or breastfeeding and at least 1 of the following conditions applies:\n\n 1. Is not an IOCBP, OR\n 2. Is an IOCBP and using a non-hormonal contraceptive method that is highly effective (with a failure rate of \\< 1% per year).\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator.\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, any components of the IMP, or other substance (not including seasonal allergies), unless approved by the investigator and medical monitor.\n* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions.\n* History or current diagnosis of uncontrolled or significant cardiac disease indicating significant risk of safety for participation in the study, including any of the following:\n\n i. History of myocardial infarction ii. Heart failure iii. Unstable angina (within 6 months of Day -1) iv. High-risk or symptomatic cardiac arrhythmias (eg, sustained ventricular tachycardia, second- or third-degree atrioventricular block without a pacemaker) v. Hypertension.\n* Other protocol-defined Inclusion/Exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT06801418', 'briefTitle': 'Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mirati Therapeutics Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Randomized, 2-sequence, 4-period, Fully-replicate, Bioequivalence Study Between Adagrasib Reference Tablets and High Drug Load Tablets in Healthy Adult Participants', 'orgStudyIdInfo': {'id': 'CA239-0020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adagrasib sequence A', 'interventionNames': ['Drug: Adagrasib']}, {'type': 'EXPERIMENTAL', 'label': 'Adagrasib sequence B', 'interventionNames': ['Drug: Adagrasib']}], 'interventions': [{'name': 'Adagrasib', 'type': 'DRUG', 'otherNames': ['BMS-986503', 'MRTX849'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Adagrasib sequence A', 'Adagrasib sequence B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219-9746', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'Local Institution - 0003', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}, {'zip': '78209-1028', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Local Institution - 0002', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84124-1365', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mirati Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}