COMPLETED

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

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Conditions

Healthy VolunteersBMS-986460, bioavailability, healthy adult male, crossover, SAD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-03-19
Study Completion:2025-12-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06877702

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.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * 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.
  2. * Participants with left ventricular ejection fraction (≤ 50%) at screening are excluded.
  3. * Participants with history of anaphylactic reactions are excluded.
  4. * 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.
  5. * Participants with history of Gilbert's syndrome are excluded.
  6. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0001
Lenexa, Kansas, 66219
United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19
Study Completion Date2025-12-17

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2025-12-17

Terms related to this study

Keywords Provided by Researchers

  • BMS-986460, bioavailability, healthy adult male, crossover, SAD

Additional Relevant MeSH Terms

  • Healthy Volunteers