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

NCT ID: NCT05567510

Last Updated: 2023-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2022-12-27

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BMS-986369

Group Type: EXPERIMENTAL

BMS-986369

Intervention Type: DRUG

Specified dose on specified days

Interventions

BMS-986369

Specified dose on specified days

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, United States

Countries

United States

Related Links

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

http://www.fda.gov/safety/medwatch/safetyinformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

CA073-002

Identifier Type: -

Identifier Source: org_study_id