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OpenTrials
Completed

NCT Number: NCT06715683

A Study to Evaluate Comparative Bioavailability of BMS-986278 in Healthy Participants

This is a trial to evaluate the comparative bioavailability of BMS-986278 to-be-marketed formulation compared to the phase 3 clinical trial formulation in healthy participants.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials (ACT)

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy female individuals not of childbearing potential (INOCBP) and males, healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory assessment results as determined by the investigator.
  • Body mass index (BMI) 18.0 to 32.0 kg/m2, inclusive.
  • Body weight ≥ 50 kg for males and ≥ 45 kg for females.

Exclusion criteria

  • Any significant acute or chronic medical illness as determined by the investigator.
  • Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease or other procedures (eg, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: uncomplicated appendectomy and hernia repair are acceptable).
  • Any major surgery within 4 weeks of study intervention administration on Day 1, including GI surgery (eg, cholecystectomy and any other GI surgery or perforation that could impact upon the absorption of study intervention [uncomplicated appendectomy and hernia repair are acceptable]).
  • History of known risk of bleeding.
  • Inability to tolerate oral medication.
  • Individuals (only females) who are of childbearing potential.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

BMS-986278 Batched method, Dose A

Drug

Specified dose on specified days

BMS-986278 Batched method, Dose B

Drug

Specified dose on specified days

BMS-986278 Continuous method

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Up to Day 24

  2. Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))

    Time frame: Up to Day 24

  3. Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))

    Time frame: Up to Day 24

Secondary outcomes

  1. Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Up to Day 24

  2. Terminal Phase Half-life (T-HALF)

    Time frame: Up to Day 24

  3. Apparent Total Body Clearance (CLT/F)

    Time frame: Up to Day 24

  4. Apparent Volume of Distribution (Vz/F)

    Time frame: Up to Day 24

  5. Number of Participants With Adverse Events (AEs)

    Time frame: Up to 28 Days Post-discontinuation of Study Intervention

  6. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Up to Day 25

  7. Number of Participants With Vital Sign Abnormalities

    Time frame: Up to Day 25

  8. Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 25

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Randomized, 2-Part, 4-Period, 2-Sequence, Fully Replicated Crossover Study to Assess the Comparative Bioavailability of BMS-986278 To-be-marketed Formulation Compared to the Phase 3 Clinical Trial Formulation in Healthy Participants

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2024
Registry last updated
Apr 4, 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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