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

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: Not yet recruiting
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: Rabeprazole; Drug: BMS-986365

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • Local Institution - 0001
      • Contact: Site 0001

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

10

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 2: Cohort 4 BMS-986365 Dose 8 Fasted	Drug: BMS-986365; Specified dose on specified days; Other Names: CC-94676
Experimental: Part 2: Cohort 4 BMS-986365 Dose 9 Fed	Drug: BMS-986365; Specified dose on specified days; Other Names: CC-94676
Experimental: Part 2: Cohort 5 BMS-986365 Dose 10 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365	Drug: Rabeprazole; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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
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
Number of participants with clinical laboratory abnormalities	Up to Day 75
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 75

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Estimated): May 16, 2024
• Primary Completion (Estimated): November 18, 2024
• Study Completion (Estimated): December 10, 2024

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): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Relative Bioavailability; Food Effect; CC-94676; Proton Pump Inhibitor; Healthy Male Volunteers; BMS-986365
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• 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