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

Description

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.

Conditions

Healthy Volunteers

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Study Overview

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Study Details

Study 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.

A Phase 1, 2-Part, Open-label Study to Evaluate Relative Bioavailability of Alternate Formulations of BMS-986460 in Healthy Adult Male Participants (Part 1), and a Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986460 in Healthy Adult Male Participants (Part 2)

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

Condition
Healthy Volunteers
Intervention / Treatment

-

Contacts and Locations

Lenexa

ICON Lenexa, Lenexa, Kansas, United States, 66219

Lenexa

Local Institution - 0002, Lenexa, Kansas, United States, 66219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 60 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2025-08-29