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

NCT06568458 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1026
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (11)

• 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

• 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

Study Arms (8)

Part I: Period A

EXPERIMENTAL

Drug: Nintedanib

Part I: Period B

EXPERIMENTAL

Drug: BMS 986278

Part I: Period C

EXPERIMENTAL

Drug: Nintedanib; Drug: BMS 986278

Part II: Period 1

EXPERIMENTAL

Drug: BMS 986278

Part II: Period 2

EXPERIMENTAL

Drug: BMS 986278

Part II: Period 3

EXPERIMENTAL

Drug: BMS 986278

Part III: Period 1

EXPERIMENTAL

Drug: BMS 986278

Part III: Period 2

EXPERIMENTAL

Drug: BMS 986278

Interventions

Nintedanib DRUG

Specified Dose on specified days

Part I: Period A; Part I: Period C

BMS 986278 DRUG

Specified dose on specified days

Part I: Period B; Part I: Period C; Part II: Period 1; Part II: Period 2; Part II: Period 3; Part III: Period 1; Part III: Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

nintedanib

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 23, 2024
• Study Start: September 19, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)