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Completed

NCT Number: 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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nintedanib

Drug

Specified Dose on specified days

BMS 986278

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum Observed Serum Concentration (Cmax)

    Time frame: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)

  2. Area under the plasma concentration-time curve within a dosing interval AUC(TAU)

    Time frame: Day 4, 17 and 21 of Part 1

  3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)

    Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

  4. Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)

    Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

Secondary outcomes

  1. Number of participants with non-serious AEs (Adverse events)

    Time frame: Up to 28 Days post discontinuation of dosing

  2. Number of participants with Serious AEs

    Time frame: Up to 28 Days post discontinuation of dosing

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to 28 Days post discontinuation of dosing

  4. Number of participants with Physical examination abnormalities

    Time frame: Up to 28 Days post discontinuation of dosing

  5. Number of participants with vital sign abnormalities

    Time frame: Up to 28 Days post discontinuation of dosing

  6. Number of participants with 12-lead electrocardiogram (ECG) abnormalities

    Time frame: Up to 28 Days post discontinuation of dosing

  7. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 28 Days post discontinuation of dosing

  8. Time of maximum observed plasma concentration (Tmax)

    Time frame: Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)

  9. Apparent terminal phase half-life (T-HALF)

    Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

  10. Apparent total body clearance (CLT/F)

    Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

  11. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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