A Phase 1, Single-center, Open-label Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

Celgene1 site in 1 country8 target enrollmentFebruary 2, 2024

ConditionsHealthy Volunteers

Interventions[14C]-BMS-986368

Drugs[14C]-BMS-986368

Overview

Phase: Phase 1
Intervention: [14C]-BMS-986368
Conditions: Healthy Volunteers
Sponsor: Celgene
Enrollment: 8
Locations: 1
Primary Endpoint: Maximum observed concentration (Cmax)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.

Registry

clinicaltrials.gov

Start Date

February 2, 2024

End Date

April 3, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Celgene

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
•Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\[m\])\^2

Exclusion Criteria

•History of hypokalemia.
•Any significant acute or chronic medical illness as determined by the investigator.
•Participant has a history of syncope in the year prior to Day
•Other protocol-defined incusion/exclusion criteria apply.

Arms & Interventions

[14C]-BMS-986368

Intervention: [14C]-BMS-986368

Outcomes

Primary Outcomes

Maximum observed concentration (Cmax)

Time Frame: Up to Day 15

Total Radioactivity (TRA)

Time Frame: Up to Day 30

Time of maximum observed concentration (Tmax)

Time Frame: Up to Day 15

Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))

Time Frame: Up to Day 15

Secondary Outcomes

Number of participants with Adverse Events (AEs)(Up to Day 36)
Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 30)
Number of participants with physical examination abnormalities(Up to Day 30)
Number of participants with clinical laboratory test abnormalities(Up to Day 30)
Number of participants with Serious AEs (SAEs)(Up to Day 36)
Number of participants with AEs leading to discontinuation(Up to Day 36)
Number of participants with vital sign abnormalities(Up to Day 30)