Status:
RECRUITING
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-60 years
Phase:
PHASE1
Brief 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 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.
Exclusion
Key Trial Info
Start Date :
March 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 17 2025
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06877702
Start Date
March 19 2025
End Date
December 17 2025
Last Update
November 17 2025
Active Locations (2)
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1
ICON Lenexa
Lenexa, Kansas, United States, 66219
2
Local Institution - 0002
Lenexa, Kansas, United States, 66219