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

NCT06417229 | Completed Phase 1 FDA Drug

• 1 other identifier: CA228-1011
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• 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

• Incidence of serious adverse events (SAE)

  Up to Day 75

• Number of participants with physical examination abnormalities

  Up to Day 75

• Number of participants with vital sign abnormalities

  Up to Day 75

Study Arms (11)

Part 1: Cohort 1 BMS-986365 Dose 1

EXPERIMENTAL

Drug: BMS-986365

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

EXPERIMENTAL

Drug: BMS-986365

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

EXPERIMENTAL

Drug: BMS-986365

Part 1: Cohort 3 BMS-986365 Dose 4

EXPERIMENTAL

Drug: BMS-986365

Part 1: Cohort 6 BMS-986365 Dose 5

EXPERIMENTAL

Drug: BMS-986365

Part 1: Cohort 7 BMS-986365 Dose 6

EXPERIMENTAL

Drug: BMS-986365

Part 1: Cohort 8 BMS-986365 Dose 7

EXPERIMENTAL

Drug: BMS-986365

Part 1: Cohort 9 BMS-986365 Dose 8

EXPERIMENTAL

Drug: BMS-986365

Part 2: Cohort 4 BMS-986365 Dose 9 Fasted

EXPERIMENTAL

Drug: BMS-986365

Part 2: Cohort 4 BMS-986365 Dose 10 Fed

EXPERIMENTAL

Drug: BMS-986365

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

EXPERIMENTAL

Drug: BMS-986365; Drug: Rabeprazole

Interventions

BMS-986365 DRUG

Specified dose on specified days

Also known as: CC-94676

Part 1: Cohort 1 BMS-986365 Dose 1; Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1; Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2; Part 1: Cohort 3 BMS-986365 Dose 4; Part 1: Cohort 6 BMS-986365 Dose 5; Part 1: Cohort 7 BMS-986365 Dose 6; Part 1: Cohort 8 BMS-986365 Dose 7; Part 1: Cohort 9 BMS-986365 Dose 8; Part 2: Cohort 4 BMS-986365 Dose 10 Fed; Part 2: Cohort 4 BMS-986365 Dose 9 Fasted; Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365

Rabeprazole DRUG

Specified dose on specified days

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Local Institution - 0001

Lenexa, Kansas, 66219, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

Rabeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 16, 2024
• Study Start: May 28, 2024
• Primary Completion: February 19, 2025
• Study Completion: February 19, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)