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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05567510
• Other study ID #: CA073-002
• Status: Completed
• Phase: Phase 1
• Start date: October 20, 2022
• Est. completion date: December 27, 2022

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 27, 2022
• Est. primary completion date: December 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• BMS-986369
Specified dose on specified days

Locations

Country	Name	City	State
United States	Labcorp Clinical Research Unit - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total radioactivity recovered in whole blood		Up to 22 days
Primary	Total radioactivity recovered in plasma		Up to 22 days
Primary	Total radioactivity recovered in urine		Up to 22 days
Primary	Total radioactivity recovered in feces		Up to 22 days
Primary	Total radioactivity recovered in vomit		Up to 22 days
Primary	Maximum observed plasma concentration (Cmax)		Up to 22 days
Primary	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
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])		Up to 22 days
Primary	Total radioactivity recovered in whole blood to plasma ratio		Up to 22 days
Secondary	Number of participants with adverse events (AEs)		Up to 28 days
Secondary	Number of participants with serious adverse events (SAEs)		Up to 28 days
Secondary	Number of participants with vital sign abnormalities		Up to 28 days
Secondary	Number of participants with electrocardiogram (ECG) abnormalities		Up to 28 days
Secondary	Number of participants with clinical laboratory test abnormalities		Up to 28 days
Secondary	Number of participants with physical examination abnormalities		Up to 28 days

External Links

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