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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of BMS-986278 and the Effects of BMS-986278 on Cardiac Repolarization in Healthy Participants

NCT ID: NCT06746402

Last Updated: 2025-10-06

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2025-09-11

Brief Summary

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The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK) of high dose of BMS-986278 in healthy participants and to assess the effect of BMS-986278 on the ECG intervals in healthy participants.

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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

Part A, a parallel model, will be followed by Part B, a 4-way crossover model.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
This is a double-blind study, with an open-label positive control in Part B.

Study Groups

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Part A

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Part B1/B2 Treatment A

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days

Part B1/B2 Treatment B

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Part B1/B2 Treatment C

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Specified dose on specified days

Part B1/B2 Treatment D

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Specified dose on specified days

Moxifloxacin

Intervention Type DRUG

Specified dose on specified days

Part B3 Treatment A

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days

Part B3 Treatment B

Group Type EXPERIMENTAL

BMS-986278

Intervention Type DRUG

Specified dose on specified days

Placebo

Intervention Type DRUG

Specified dose on specified days

Part B3 Treatment C

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Specified dose on specified days

Part B3 Treatment D

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Specified dose on specified days

Moxifloxacin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986278

Specified dose on specified days

Intervention Type DRUG

Placebo

Specified dose on specified days

Intervention Type DRUG

Moxifloxacin

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Female individuals not of childbearing potential (INOCBP) and males.
* Healthy as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
* Body mass index (BMI) 18.0 to 32.0 kg/m2 , inclusive, for Parts A and B.

Exclusion Criteria

* Any significant acute or chronic medical illness as determined by the investigator.
* History of clinically relevant cardiac disease as determined by the investigator, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for ventricular arrhythmias.
* Any significant history of disease of the cardiovascular system that in the opinion of the Investigator makes the participant unsuitable for enrollment into the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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ICON San Antonio

San Antonio, Texas, United States

Site Status

Local Institution - 0001

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Related Links

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

BMS Clinical Trial Information

https://www.BMSClinicalTrials.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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IM027-1012

Identifier Type: -

Identifier Source: org_study_id

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