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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]BMS-986419

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704-2526
      • Labcorp Clinical Research Unit - Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]BMS-986419	Drug: [14C]BMS-986419; Specified dose on specified days; Other Names: BMS-986419; EOAI4018683

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax)	Up to Day 20
Time of maximum plasma observed concentration (Tmax)	Up to Day 20
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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 Physical Examination Abnormalities	Up to Day 30
Number of Participants with Clinical Laboratory Abnormalities	Up to Day 30

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Actual): July 5, 2023
• Study Completion (Actual): July 5, 2023

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 2, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy participants; Healthy volunteer; Radioactivity; Metabolite profile; BMS-986419
• Other Study ID Numbers: CN007-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No