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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986278 Batched method, Dose A; Drug: BMS-986278 Batched method, Dose B; Drug: BMS-986278 Continuous method

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials (ACT)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1, Sequence 1	Drug: BMS-986278 Batched method, Dose A; Specified dose on specified days; Drug: BMS-986278 Batched method, Dose B; Specified dose on specified days
Experimental: Part 1, Sequence 2	Drug: BMS-986278 Batched method, Dose A; Specified dose on specified days; Drug: BMS-986278 Batched method, Dose B; Specified dose on specified days
Experimental: Part 2, Sequence 1	Drug: BMS-986278 Batched method, Dose A; Specified dose on specified days; Drug: BMS-986278 Continuous method; Specified dose on specified days
Experimental: Part 2, Sequence 2	Drug: BMS-986278 Batched method, Dose A; Specified dose on specified days; Drug: BMS-986278 Continuous method; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum Observed Plasma Concentration (Cmax)	Up to Day 24
Area Under the Concentration-time From Time Zero to Time Last Qualifiable Concentration (AUC(0-T))	Up to Day 24
Area Under the Concentration-time From Time Zero Extrapolated to Infinite Time (AUC(INF))	Up to Day 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Time of Maximum Observed Plasma Concentration (Tmax)	Up to Day 24
Terminal Phase Half-life (T-HALF)	Up to Day 24
Apparent Total Body Clearance (CLT/F)	Up to Day 24
Apparent Volume of Distribution (Vz/F)	Up to Day 24
Number of Participants With Adverse Events (AEs)	Up to 28 Days Post-discontinuation of Study Intervention
Number of Participants With Clinical Laboratory Abnormalities	Up to Day 25
Number of Participants With Vital Sign Abnormalities	Up to Day 25
Number of Participants With 12-Lead Electrocardiogram (ECG) Abnormalities	Up to Day 25

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Actual): March 16, 2025
• Study Completion (Actual): March 16, 2025

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Pharmacokinetics; BMS-986278; Comparative Bioavailability
• Other Study ID Numbers: IM027-1035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No