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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05847439
• Other study ID #: CN007-1004
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2023
• Est. completion date: July 5, 2023

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: July 5, 2023
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• [14C]BMS-986419
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	Maximum observed plasma concentration (Cmax)		Up to Day 20
Primary	Time of maximum plasma observed concentration (Tmax)		Up to Day 20
Primary	Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])		Up to Day 20
Primary	Total radioactivity recovered in urine (UR)		Up to Day 30
Primary	Total radioactivity recovered in feces (FR)		Up to Day 30
Primary	Total radioactivity recovered in bile (BR)		Up to Day 30
Primary	Total radioactivity recovered (Rtotal)		Up to Day 30
Primary	Percent of total radioactivity recovered (%Total)		Up to Day 30
Primary	Percent of total radioactivity recovered in urine (%UR)		Up to Day 30
Primary	Percent of total radioactivity recovered in feces (%FR)		Up to Day 30
Secondary	Number of Participants with Adverse Events (AEs)		Up to Day 60
Secondary	Number of Participants with Serious AEs (SAEs)		Up to Day 60
Secondary	Number of Participants with AEs leading to discontinuation		Up to Day 60
Secondary	Number of Participants with Vital Sign Abnormalities		Up to Day 30
Secondary	Number of Participants with Electrocardiogram (ECG) Abnormalities		Up to Day 30
Secondary	Number of Participants with Physical Examination Abnormalities		Up to Day 30
Secondary	Number of Participants with Clinical Laboratory Abnormalities		Up to Day 30

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting