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 Squibb42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

BMS-986278DRUG

Specified dose on specified days

PlaceboDRUG

Specified dose on specified days

MoxifloxacinDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (2)

ICON San Antonio

San Antonio, Texas, United States

Local Institution - 0001

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Number of participants with non-serious Adverse Events (AEs)

Part A

Time frame: Until 28 days post last treatment dose

Number of participants with Serious AEs (SAEs)

Part A

Time frame: Until 28 days post last treatment dose

Number of participants with AEs leading to study intervention discontinuation

Part A

Time frame: Until 28 days post last treatment dose

Number of participants with vital sign abnormalities

Part A

Time frame: Up to Day 18

Number of participants with clinical laboratory assessment abnormalities

Part A

Time frame: Up to Day 18

Number of participants with 12-lead electrocardiogram (ECG) abnormalities

Part A

Time frame: Up to Day 18

Number of participants with physical examination abnormalities

Part A

Time frame: Up to Day 18

Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Placebo-corrected change from baseline QTcF (ΔΔQTcF)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Data from ClinicalTrials.gov

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Secondary Outcomes

Maximum observed plasma concentration (Cmax)

Part A and Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Time of maximum observed plasma concentration (Tmax)

Part A and Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Area under the plasma concentration-time curve from time zero to the end of dosing interval AUC(TAU)

Part A and Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Terminal half-life (T-HALF)

Part A

Time frame: Up to Day 18

Apparent total body clearance (CLT/F)

Part A

Time frame: Up to Day 18

Change from baseline heart rate (HR) (∆HR)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Change from baseline PR interval (∆PR)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Change from baseline QRS interval (∆QRS)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Placebo-corrected change from baseline HR (ΔΔHR)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Placebo-corrected Change from baseline PR interval (ΔΔPR)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Placebo-corrected change from baseline QRS interval (ΔΔQRS)

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with categorical outliers for QTcF

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with categorical outliers for HR

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with categorical outliers for PR interval

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with categorical outliers for QRS interval

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with treatment-emergent changes of ECG morphology

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

ΔQTcF for moxifloxacin

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

ΔΔQTcF for moxifloxacin

Part B

Time frame: Up to Day 13 of Period 4 (Each period is 17 days)

Number of participants with non-serious AEs

Part B

Time frame: Until 28 days post last treatment dose

Number of participants with SAEs

Part B

Time frame: Until 28 days post last treatment dose

Number of participants with AEs leading to study intervention discontinuation

Part B

Time frame: Until 28 days post last treatment dose

Number of participants with vital sign abnormalities

Part B

Time frame: Up to Day 18 of Period 4 (Each period is 17 days)

Number of participants with clinical laboratory assessment abnormalities

Part B

Time frame: Up to Day 17 of Period 4 (Each period is 17 days)

Number of participants with 12-lead ECG abnormalitie

Part B

Time frame: Up to Day 17 of Period 4 (Each period is 17 days)

Number of participants with physical examination abnormalities

Part B

Time frame: Up to Day 18 of Period 4 (Each period is 17 days)