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

NCT05567510 | Completed Phase 1 FDA Drug

• 1 other identifier: CA073-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Participants

Keywords

BMS-986369; Drug absorption, distribution, metabolism, and excretion (ADME)

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• 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

Study Arms (1)

BMS-986369

EXPERIMENTAL

Drug: BMS-986369

Interventions

BMS-986369 DRUG

Specified dose on specified days

BMS-986369

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, 53704-2526, United States

Location

Related Links

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

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 5, 2022
• Study Start: October 20, 2022
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: February 17, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)