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

March 4, 2025 updated by: Celgene

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part 1: Cohort 1 BMS-986365 Dose 1
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 3 BMS-986365 Dose 4
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 6 BMS-986365 Dose 5
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 7 BMS-986365 Dose 6
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 8 BMS-986365 Dose 7
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 1: Cohort 9 BMS-986365 Dose 8
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 2: Cohort 4 BMS-986365 Dose 9 Fasted
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 2: Cohort 4 BMS-986365 Dose 10 Fed
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676
Experimental: Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365
Drug: Rabeprazole
Specified dose on specified days
Drug: BMS-986365
Specified dose on specified days
Other Names:
  • CC-94676

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celgene

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 28, 2024

Primary Completion (Actual)

February 19, 2025

Study Completion (Actual)

February 19, 2025

Study Registration Dates

First Submitted

May 13, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA228-1011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and research/disclosurecommitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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