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

NCT06715683 | Completed Phase 1 FDA Drug

• 1 other identifier: IM027-1035
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Comparative Bioavailability; BMS-986278

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• 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

Study Arms (4)

Part 1, Sequence 1

EXPERIMENTAL

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

Part 1, Sequence 2

EXPERIMENTAL

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

Part 2, Sequence 1

EXPERIMENTAL

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

Part 2, Sequence 2

EXPERIMENTAL

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

Interventions

BMS-986278 Batched method, Dose A DRUG

Specified dose on specified days

Part 1, Sequence 1; Part 1, Sequence 2; Part 2, Sequence 1; Part 2, Sequence 2

BMS-986278 Batched method, Dose B DRUG

Specified dose on specified days

Part 1, Sequence 1; Part 1, Sequence 2

BMS-986278 Continuous method DRUG

Specified dose on specified days

Part 2, Sequence 1; Part 2, Sequence 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Anaheim Clinical Trials (ACT)

Anaheim, California, 92801, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: December 4, 2024
• Study Start: December 12, 2024
• Primary Completion: March 16, 2025
• Study Completion: March 16, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (1)