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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Moxifloxacin; Drug: Placebo; Drug: BMS-986278

Study type: Interventional

Funder types: Industry

Identifiers

NCT06746402

IM027-1012

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.
• Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 9 patient groups

Part A

Experimental group

Treatment:

Drug: BMS-986278

Drug: Placebo

Part B1/B2 Treatment A

Experimental group

Treatment:

Drug: BMS-986278

Part B1/B2 Treatment B

Experimental group

Treatment:

Drug: BMS-986278

Drug: Placebo

Part B1/B2 Treatment C

Experimental group

Treatment:

Drug: Placebo

Part B1/B2 Treatment D

Experimental group

Treatment:

Drug: Placebo

Drug: Moxifloxacin

Part B3 Treatment A

Experimental group

Treatment:

Drug: BMS-986278

Part B3 Treatment B

Experimental group

Treatment:

Drug: BMS-986278

Drug: Placebo

Part B3 Treatment C

Experimental group

Treatment:

Drug: Placebo

Part B3 Treatment D

Experimental group

Treatment:

Drug: Placebo

Drug: Moxifloxacin