Status:
WITHDRAWN
A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Adult Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed \[high-fat meal\]) on the drug levels after administration of BMS-986196 tabl...
Eligibility Criteria
Inclusion
- Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and body weight ≥ 50 kg.
- Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).
Exclusion
- Any significant acute or chronic medical illness in the assessment of the investigator.
- Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
- Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- Note: Other protocol-defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
September 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06034899
Start Date
September 22 2023
End Date
November 30 2023
Last Update
September 21 2023
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