Healthy Adult Volunteers
Conditions
Keywords
BMS-986196, Healthy adult participants, Pharmacokinetics, Cross-over study
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 tablet formulation at two dose levels in healthy adult participants.
Interventions
DRUGBMS-986196
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) | Predose and post-dose up to Day 10 |
| Maximum observed serum concentration (Cmax) | Predose and post-dose up to Day 10 |
| Time of Cmax (Tmax) | Predose and post-dose up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11 | Baseline, Day 11 |
| Number of participants with vital sign abnormalities | Up to Day 11 |
| Number of participants with adverse events (AEs) | Up to Day 36 |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to Day 11 |
| Number of participants with serious AEs (SAEs) | Up to Day 36 |
| Number of participants with physical examination findings | Up to Day 11 |
| Number of participants with clinical laboratory abnormalities | Up to Day 11 |
Outcome results
None listed