A Study to Assess the Extent of Drug Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 in Tablet and the Effect That Food Has on BMS-986278 in Tablet Formulations in Healthy Participants
- Registration Number
- NCT06568458
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
Inclusion Criteria
- Participants must be healthy males and females (INOCBP)
- Participant must have Body mass index (BMI) of 18.0 kg/m2 through 32.0 kg/m2, inclusive.
- Participant must have Body weight ≥ 50 kg
Exclusion Criteria
- Participant must not have current or recent GI disease
- Participant with evidence of organ dysfunction or any clinically significant deviation, as determined by investigator, from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population.
- Participant with prior exposure to BMS-986278 and exposure of any investigational drug or placebo within 4 weeks of study intervention administration.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part II: Period 2 BMS 986278 - Part III: Period 1 BMS 986278 - Part I: Period B BMS 986278 - Part II: Period 1 BMS 986278 - Part I: Period A Nintedanib - Part I: Period C Nintedanib - Part I: Period C BMS 986278 - Part II: Period 3 BMS 986278 - Part III: Period 2 BMS 986278 -
- Primary Outcome Measures
Name Time Method Maximum Observed Serum Concentration (Cmax) Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T) Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) Area under the plasma concentration-time curve within a dosing interval AUC(TAU) Day 4, 17 and 21 of Part 1 Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
- Secondary Outcome Measures
Name Time Method Apparent total body clearance (CLT/F) Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) Number of participants with vital sign abnormalities Up to 28 Days post discontinuation of dosing Number of participants with clinical laboratory abnormalities Up to 28 Days post discontinuation of dosing Number of participants with non-serious AEs (Adverse events) Up to 28 Days post discontinuation of dosing Number of participants with Physical examination abnormalities Up to 28 Days post discontinuation of dosing Apparent terminal phase half-life (T-HALF) Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2) Number of participants with AEs leading to discontinuation Up to 28 Days post discontinuation of dosing Number of participants with Serious AEs Up to 28 Days post discontinuation of dosing Number of participants with 12-lead electrocardiogram (ECG) abnormalities Up to 28 Days post discontinuation of dosing Time of maximum observed plasma concentration (Tmax) Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2) Apparent volume of distribution of terminal phase (Vz/F) Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Lenexa, Kansas, United States