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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986278 Batched method, Dose B; Drug: BMS-986278 Continuous method; Drug: BMS-986278 Batched method, Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06715683

IM027-1035

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

Part 1, Sequence 1

Experimental group

Treatment:

Drug: BMS-986278 Batched method, Dose A

Drug: BMS-986278 Batched method, Dose B

Part 1, Sequence 2

Experimental group

Treatment:

Drug: BMS-986278 Batched method, Dose A

Drug: BMS-986278 Batched method, Dose B

Part 2, Sequence 1

Experimental group

Treatment:

Drug: BMS-986278 Batched method, Dose A

Drug: BMS-986278 Continuous method

Part 2, Sequence 2

Experimental group

Treatment:

Drug: BMS-986278 Batched method, Dose A

Drug: BMS-986278 Continuous method