Study to Characterize the Effects of Cytochrome p450 1A2 Inhibition on Systemic Exposure to BMS-986165
- Registration Number
- NCT03930602
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description BMS-986165+Fluvoxamine BMS-986165 - BMS-986165 only BMS-986165 - BMS-986165+Fluvoxamine Fluvoxamine - Fluvoxamine only Fluvoxamine -
- Primary Outcome Measures
Name Time Method AUC(0-T) of BMS-986165 10 days AUC(INF) of BMS-986165 10 days Maximum observed plasma concentration (Cmax) of BMS-986165 10 days
- Secondary Outcome Measures
Name Time Method Percentage of participants with Serious Adverse events (SAEs) and Death From screening up to end of drug treatment (Day 13) Fluvoxamine steady-state plasma concentrations 10 days Percentage of participants with Adverse events (AEs) From screening up to end of drug treatment (Day 13) 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) leading to discontinutation From screening up to end of drug treatment (Day 13)
Trial Locations
- Locations (1)
ICON Plc (PRA Health Sciences)
🇺🇸Salt Lake City, Utah, United States