CompletedPhase 1

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

United States85 participantsStarted 2025-03-19

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Up to approximately Day 43

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

Timeframe: Up to approximately Day 43

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

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

Timeframe: Up to approximately Day 21

Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460

Timeframe: Up to approximately Day 21

Trial details

NCT IDNCT06877702

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-17

View on ClinicalTrials.gov More Healthy Volunteers trials

Who can participate

Age range18 Years – 60 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Up to approximately Day 43

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

Timeframe: Up to approximately Day 43

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

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Vital Sign Abnormalities

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities

Timeframe: Up to approximately Day 21

Part 1: Number of Participants With Clinically Significant 12-lead Electrocardiogram (ECG) Findings

Timeframe: Up to approximately Day 21

Part 1: Maximum Observed Plasma Concentration (Cmax) of BMS-986460

Timeframe: Up to approximately Day 21