A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Registration Number
- NCT05852769
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.
Exclusion Criteria
- History of rhabdomyolysis.
- History of peptic ulcer disease or significant GI bleeding.
- History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BMS-986196 and/or Cocktail Probe Substrate Drugs Pravastatin - BMS-986196 and/or Cocktail Probe Substrate Drugs BMS-986196 - BMS-986196 and/or Cocktail Probe Substrate Drugs Caffeine - BMS-986196 and/or Cocktail Probe Substrate Drugs Montelukast - BMS-986196 and/or Cocktail Probe Substrate Drugs Flurbiprofen - BMS-986196 and/or Cocktail Probe Substrate Drugs Omeprazole - BMS-986196 and/or Cocktail Probe Substrate Drugs Midazolam - BMS-986196 and/or Cocktail Probe Substrate Drugs Digoxin -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) Up to 26 days Maximum observed plasma concentration (Cmax) Up to 26 days Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T]) Up to 26 days
- Secondary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) Up to 52 days Number of participants with vital sign abnormalities Up to 28 days Number of participants with physical examination abnormalities Up to 28 days Number of participants with clinical laboratory abnormalities Up to 28 days Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score Up to 28 days Time of maximum observed serum concentration (Tmax) Up to 26 days Apparent terminal phase half-life (T-Half) Up to 26 days Apparent total body clearance (CLT/F) Up to 26 days Number of participants with electrocardiogram (ECG) abnormalities Up to 21 days
Trial Locations
- Locations (1)
ICON plc
🇺🇸Millcreek, Utah, United States
ICON plc🇺🇸Millcreek, Utah, United States