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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986460

Study type: Interventional

Funder types: Industry

Identifiers

NCT06877702

CA125-1018

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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85 participants in 8 patient groups

Part 1: Sequence 1

Experimental group

Treatment:

Drug: BMS-986460

Part 1: Sequence 2

Experimental group

Treatment:

Drug: BMS-986460

Part 1: Sequence 3

Experimental group

Treatment:

Drug: BMS-986460

Part 2: Treatment A

Experimental group

Treatment:

Drug: BMS-986460

Part 2: Treatment B

Experimental group

Treatment:

Drug: BMS-986460

Part 2: Optional Treatment C

Experimental group

Treatment:

Drug: BMS-986460

Part 2: Optional Treatment D

Experimental group

Treatment:

Drug: BMS-986460

Part 2: Optional Treatment E

Experimental group

Treatment:

Drug: BMS-986460