Healthy Volunteers
Conditions
Keywords
BMS-986196
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.
Interventions
DRUGBMS-986196
Specified dose on specified days
DRUGCaffeine
Specified dose on specified days
DRUGMontelukast
Specified dose on specified days
DRUGFlurbiprofen
Specified dose on specified days
DRUGOmeprazole
Specified dose on specified days
DRUGMidazolam
Specified dose on specified days
DRUGDigoxin
Specified dose on specified days
DRUGPravastatin
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 26 days |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) | 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
| Measure | Time frame |
|---|---|
| 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 electrocardiogram (ECG) abnormalities | Up to 21 days |
| Time of maximum observed serum concentration (Tmax) | Up to 26 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 |
| Number of participants with physical examination abnormalities | Up to 28 days |
| Apparent terminal phase half-life (T-Half) | Up to 26 days |
| Apparent total body clearance (CLT/F) | Up to 26 days |
Countries
United States
Outcome results
None listed