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

NCT ID: NCT06715683

Last Updated: 2025-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-03-16

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1, Sequence 1

Group Type EXPERIMENTAL

BMS-986278 Batched method, Dose A

Intervention Type DRUG

Specified dose on specified days

BMS-986278 Batched method, Dose B

Intervention Type DRUG

Specified dose on specified days

Part 1, Sequence 2

Group Type EXPERIMENTAL

BMS-986278 Batched method, Dose A

Intervention Type DRUG

Specified dose on specified days

BMS-986278 Batched method, Dose B

Intervention Type DRUG

Specified dose on specified days

Part 2, Sequence 1

Group Type EXPERIMENTAL

BMS-986278 Batched method, Dose A

Intervention Type DRUG

Specified dose on specified days

BMS-986278 Continuous method

Intervention Type DRUG

Specified dose on specified days

Part 2, Sequence 2

Group Type EXPERIMENTAL

BMS-986278 Batched method, Dose A

Intervention Type DRUG

Specified dose on specified days

BMS-986278 Continuous method

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986278 Batched method, Dose A

Specified dose on specified days

Intervention Type DRUG

BMS-986278 Batched method, Dose B

Specified dose on specified days

Intervention Type DRUG

BMS-986278 Continuous method

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Anaheim Clinical Trials (ACT)

Anaheim, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM027-1035

Identifier Type: -

Identifier Source: org_study_id

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