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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]-BMS-986368

• Registration Number: NCT06227975
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-19
• Study First Submitted QC: 2024-01-19
• Study First Posted: 2024-01-29
• Study Start: 2024-02-02
• Primary Completion: 2024-04-03
• Study Completion: 2024-04-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-10
• Last Update Posted: 2024-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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 1.

Other protocol-defined incusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]-BMS-986368	[14C]-BMS-986368	-

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Up to Day 15
Total Radioactivity (TRA)	Up to Day 30
Time of maximum observed concentration (Tmax)	Up to Day 15
Area under the concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))	Up to Day 15

Secondary Outcome Measures

Name	Time	Method
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 AEs leading to discontinuation	Up to Day 36
Number of participants with vital sign abnormalities	Up to Day 30
Number of participants with Serious AEs (SAEs)	Up to Day 36

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 Madison, Wisconsin, United States