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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06715683

Run by

Bristol-Myers Squibb

People needed

48

Starts

2024-12-12

Expected to finish

2025-03-16

Last updated by the study team

2025-04-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Anaheim Clinical Trials (ACT) — Anaheim, California, United States

Full record on ClinicalTrials.gov

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