Clinical trial NCT06568458: 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
Official title: A Phase 1, 3-Part, Open-label Study to Assess the Pharmacokinetic Interaction Between BMS-986278 and Nintedanib, the Relative Bioavailability of BMS-986278 Tablet Formulations, and the Food Effect on the Pharmacokinetics of BMS-986278 When Orally Administered as a Phase 3 Tablet Formulation in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
measure: Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
timeFrame: Day 4, 17 and 21 of Part 1
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
timeFrame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
timeFrame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Secondary outcomes:
measure: Number of participants with non-serious AEs (Adverse events)
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with Serious AEs
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with Physical examination abnormalities
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with 12-lead electrocardiogram (ECG) abnormalities
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 28 Days post discontinuation of dosing
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)
measure: Apparent terminal phase half-life (T-HALF)
timeFrame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
measure: Apparent total body clearance (CLT/F)
timeFrame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
measure: Apparent volume of distribution of terminal phase (Vz/F)
timeFrame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Local Institution - 0001
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: