A Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: [14C]BMS-986419

• Registration Number: NCT05847439
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this study is to assess the pharmacokinetics (PK), metabolite profile, routes and extent of elimination, mass balance, as well as safety and tolerability of \[14C\]BMS-986419 in healthy male participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-27
• Study First Submitted QC: 2023-04-27
• Study Start: 2023-05-05
• Study First Posted: 2023-05-06
• Primary Completion: 2023-07-05
• Study Completion: 2023-07-05
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-29
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

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

Inclusion Criteria

• Body mass index between 18.0 and 33.0 kilograms/meter square (kg/m^2), inclusive, at screening. Body mass index = weight (kg)/(height [m])2.
• Healthy male participants as determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [for example, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -2).

Exclusion Criteria

• Any significant acute or chronic medical conditions.
• Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery (for example, cholecystectomy and any other gastrointestinal surgery) that could impact the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
• Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could impact the absorption of study treatment.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[14C]BMS-986419	[14C]BMS-986419	-

Primary Outcome Measures

Name	Time	Method
Maximum observed plasma concentration (Cmax)	Up to Day 20
Time of maximum plasma observed concentration (Tmax)	Up to Day 20
Percent of total radioactivity recovered (%Total)	Up to Day 30
Percent of total radioactivity recovered in urine (%UR)	Up to Day 30
Percent of total radioactivity recovered in feces (%FR)	Up to Day 30
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])	Up to Day 20
Total radioactivity recovered in urine (UR)	Up to Day 30
Total radioactivity recovered in feces (FR)	Up to Day 30
Total radioactivity recovered in bile (BR)	Up to Day 30
Total radioactivity recovered (Rtotal)	Up to Day 30

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Physical Examination Abnormalities	Up to Day 30
Number of Participants with Adverse Events (AEs)	Up to Day 60
Number of Participants with Serious AEs (SAEs)	Up to Day 60
Number of Participants with AEs leading to discontinuation	Up to Day 60
Number of Participants with Vital Sign Abnormalities	Up to Day 30
Number of Participants with Electrocardiogram (ECG) Abnormalities	Up to Day 30
Number of Participants with Clinical Laboratory Abnormalities	Up to Day 30

Trial Locations

Locations (1)

Labcorp Clinical Research Unit - Madison; 🇺🇸 Madison, Wisconsin, United States