Healthy Participants
Conditions
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
Interventions
DRUGNintedanib
Specified Dose on specified days
DRUGBMS 986278
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 within a dosing interval AUC(TAU) | Day 4, 17 and 21 of Part 1 |
| 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 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
| Measure | Time frame |
|---|---|
| Number of participants with Physical examination abnormalities | Up to 28 Days post discontinuation of dosing |
| Number of participants with vital sign abnormalities | 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 |
| 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) |
| 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 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) |
| 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 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 Serious AEs | Up to 28 Days post discontinuation of dosing |
| Number of participants with AEs leading to discontinuation | Up to 28 Days post discontinuation of dosing |
Countries
United States
Outcome results
None listed