Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants

Celgene

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Rabeprazole; Drug: BMS-986365

Study type: Interventional

Funder types: Industry

Identifiers

NCT06417229

CA228-1011

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.

Enrollment: 102 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
• Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.

Exclusion criteria

• Any significant acute or chronic illness.
• Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
• History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
• Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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102 participants in 11 patient groups

Part 1: Cohort 1 BMS-986365 Dose 1

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 3 BMS-986365 Dose 4

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 6 BMS-986365 Dose 5

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 7 BMS-986365 Dose 6

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 8 BMS-986365 Dose 7

Experimental group

Treatment:

Drug: BMS-986365

Part 1: Cohort 9 BMS-986365 Dose 8

Experimental group

Treatment:

Drug: BMS-986365

Part 2: Cohort 4 BMS-986365 Dose 9 Fasted

Experimental group

Treatment:

Drug: BMS-986365

Part 2: Cohort 4 BMS-986365 Dose 10 Fed

Experimental group

Treatment:

Drug: BMS-986365

Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365

Experimental group

Treatment:

Drug: BMS-986365

Drug: Rabeprazole