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

A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06417229

Enrollment

102

Registered

2024-05-16

Start date

2024-05-28

Completion date

2025-02-19

Last updated

2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

BMS-986365, Pharmacokinetics, Relative Bioavailability, Healthy Male Volunteers, CC-94676, Food Effect, Proton Pump Inhibitor

Brief summary

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.

Interventions

DRUGBMS-986365

Specified dose on specified days

DRUGRabeprazole

Specified dose on specified days

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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/

Design outcomes

Primary

Measure	Time frame
Maximum observed plasma concentration (Cmax)	Up to Day 75
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]	Up to Day 75
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]	Up to Day 75

Secondary

Measure	Time frame
To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation	Up to Day 75
Incidence of adverse events (AE)	Up to Day 75
Number of participants with vital sign abnormalities	Up to Day 75
Number of participants with physical examination abnormalities	Up to Day 75
Incidence of serious adverse events (SAE)	Up to Day 75
Number of participants with clinical laboratory abnormalities	Up to Day 75
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 75

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026