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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS 986278; Drug: Nintedanib

Study type: Interventional

Funder types: Industry

Identifiers

NCT06568458

IM027-1026

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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71 participants in 8 patient groups

Part I: Period A

Experimental group

Treatment:

Drug: Nintedanib

Part I: Period B

Experimental group

Treatment:

Drug: BMS 986278

Part I: Period C

Experimental group

Treatment:

Drug: Nintedanib

Drug: BMS 986278

Part II: Period 1

Experimental group

Treatment:

Drug: BMS 986278

Part II: Period 2

Experimental group

Treatment:

Drug: BMS 986278

Part II: Period 3

Experimental group

Treatment:

Drug: BMS 986278

Part III: Period 1

Experimental group

Treatment:

Drug: BMS 986278

Part III: Period 2

Experimental group

Treatment:

Drug: BMS 986278