Healthy
Conditions
Brief summary
To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)
Interventions
DRUGBMS-986165
Participants will receive BMS-986165.
DRUGFluvoxamine
Participants will receive fluvoxamine.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator. * Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening. * Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) \> 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
Exclusion criteria
* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, * Any major surgery within 4 weeks of study drug administration * Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986165 | 10 days |
| AUC(0-T) of BMS-986165 | 10 days |
| AUC(INF) of BMS-986165 | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants with Adverse events (AEs) leading to discontinutation | From screening up to end of drug treatment (Day 13) |
| Fluvoxamine steady-state plasma concentrations | 10 days |
| Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs | From screening up to end of drug treatment (Day 13) |
| Percentage of participants with Adverse events (AEs) | From screening up to end of drug treatment (Day 13) |
| Percentage of participants with Serious Adverse events (SAEs) and Death | From screening up to end of drug treatment (Day 13) |
Countries
United States
Outcome results
None listed