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

Last updated: May 14, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

BMS-986460

Clinical Study ID

NCT06877702
CA125-1018
  • Ages 18-60
  • Male
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participants must be healthy as determined by no clinically significant deviationfrom normal in medical history, physical examination, vital signs, 12-lead ECGs,echocardiogram or clinical laboratory assessments, as determined by theinvestigator.

  • Participants must have a Body mass index (BMI) between 18.0 and 35.0 kilograms/metersquare (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

Exclusion Criteria:

  • Participants with prior exposure to BMS-986460 or with a prior history of heartfailure, ischemic heart diseases, clinically significant cardiac arrythmias, or longQT syndrome are excluded.

  • Participants with left ventricular ejection fraction (≤ 50%) at screening areexcluded.

  • 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 theabsorption of study intervention are excluded.

  • Participants with history of Gilbert's syndrome are excluded.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 56
Treatment Group(s): 1
Primary Treatment: BMS-986460
Phase: 1
Study Start date:
March 19, 2025
Estimated Completion Date:
August 29, 2025

Connect with a study center

  • ICON Lenexa

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Local Institution - 0001

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Local Institution - 0002

    Lenexa, Kansas 66219
    United States

    Site Not Available

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