A Single-dose Study to Evaluate the Safety, Tolerability, Drug Levels, and Relative Biological Availability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants

Bristol-Myers Squibb85 enrolled

Overview

The purpose of this study is to assess the safety, tolerability, drug levels, and relative bioavailability of alternate formulations of BMS-986460 in healthy adult male participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

BMS-986460DRUG

Specified dose on specified days.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria * Participants must be healthy as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, 12-lead ECGs, echocardiogram or clinical laboratory assessments, as determined by the investigator. * Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/meter square (kg/m2), inclusive. * Male participants who are sexually active with individuals of childbearing potential (IOCBP) must agree to follow instructions for methods of contraception. Exclusion Criteria: * Participants with prior exposure to BMS-986460 or with a prior history of heart failure, ischemic heart diseases, clinically significant cardiac arrythmias, or long QT syndrome are excluded. * Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded. * Participants with history of anaphylactic reactions are excluded. * Participants with current or recent (within 3 months of intervention administration) gastrointestinal disease that, in the opinion of the investigator, could affect the absorption of study intervention are excluded. * Participants with history of Gilbert's syndrome are excluded. * Other protocol-defined Inclusion/Exclusion criteria apply.

Locations (1)

Local Institution - 0001

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Part 1: Number of Participants With Adverse Events (AEs)

Time frame: Up to approximately Day 43

Part 1: Number of Participants With Serious AEs (SAEs)

Time frame: Up to approximately Day 43

Part 1: Number of Participants With Clinically Significant Physical Evaluation (PE) Findings