A Study to Evaluate the Metabolism and Excretion of BMS-986369 in Healthy Male Participants

A Phase 1, Single-center, Open-label Study to Evaluate the Metabolism and Excretion of [14C] BMS-986369 in Healthy Male Participants

The purpose of the study is to assess mass balance, biotransformation, and excretion of BMS-986369 following study drug administration.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: BMS-986369

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Labcorp Clinical Research Unit - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy male participants, of any race, determined by the investigator to have no significant deviation from normal in medical history or physical examination, which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data in 12-lead ECG measurements, vital signs, and clinical laboratory determinations at screening and/or check-in.
• Body mass index (BMI) of 18.0 through 33.0 kilogram meter squared (kg/m^2), inclusive. BMI = weight kg/height m^2.
• Absolute neutrophil counts must be greater than 2,500 per microliter (μL) at screening and Day -1.

Exclusion Criteria:

• Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study.
• Current or recent (within 3 months of study intervention administration) history of clinically significant endocrine, GI, cardiovascular, peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities/diseases.
• Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion (ADME) (eg, bariatric procedure). Appendectomy, cholecystectomy, and uncomplicated hernia repair are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.

Prior/Concomitant Therapy

• Participant has participated in another investigational trial within 4 weeks prior to screening. For participants who have participated in an investigational trial where no trial drug was administered or invasive procedure performed, the waiting interval may be eliminated.
• Participant has received a vaccination, including coronavirus disease 2019 (COVID-19) vaccine, within 30 days prior to the IP dose or plans to receive vaccination within 2 months after dosing.
• Participant has used a prescribed systemic or topical medication (eg, analgesics, anesthetics, anti-coagulants, etc.) within 30 days prior to the first dose administration. Exceptions may be made on a case-by-case basis if considered not to interfere with study objectives as agreed to by the investigator and Sponsor's Medical Monitor.
• Use of CYP3A inducers (eg, St. John's wort) and inhibitors (eg, grapefruit juice) within 30 days prior to dosing.
• Participant has used any non-prescribed systemic or topical medications (for example, vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration. Exceptions may be made on a case-by-case basis if considered not to interfere with study objectives as agreed to by the investigator and Sponsor's Medical Monitor (eg, occasional use of acetaminophen).
• Participant has received immunization with a live or live-attenuated vaccine within 2 months prior to dosing or is planning to receive immunization with a live or non-live vaccine for 2 months following dosing.
• Participated in a radiolabeled drug study, where exposures are known to the investigator, within the previous 4 months prior to check-in (Day -1); or participated in a radiolabeled drug study, where exposures are not known to the investigator, within the previous 6 months prior to check-in (Day -1). The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR-recommended levels considered safe, per US Title 21 CFR 361.15: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMS-986369	Drug: BMS-986369; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total radioactivity recovered in whole blood	Up to 22 days
Total radioactivity recovered in plasma	Up to 22 days
Total radioactivity recovered in urine	Up to 22 days
Total radioactivity recovered in feces	Up to 22 days
Total radioactivity recovered in vomit	Up to 22 days
Maximum observed plasma concentration (Cmax)	Up to 22 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])	Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Up to 22 days
Total radioactivity recovered in whole blood to plasma ratio	Up to 22 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to 28 days
Number of participants with serious adverse events (SAEs)	Up to 28 days
Number of participants with vital sign abnormalities	Up to 28 days
Number of participants with electrocardiogram (ECG) abnormalities	Up to 28 days
Number of participants with clinical laboratory test abnormalities	Up to 28 days
Number of participants with physical examination abnormalities	Up to 28 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): December 27, 2022
• Study Completion (Actual): December 27, 2022

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: BMS-986369; Drug absorption, distribution, metabolism, and excretion (ADME)
• Other Study ID Numbers: CA073-002

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 Myers 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