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

NCT05847439 | Completed Phase 1 FDA Drug

• 1 other identifier: CN007-1004
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics; Metabolite profile; Radioactivity; BMS-986419; Healthy volunteer; Healthy participants

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (7)

• 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

Study Arms (1)

[14C]BMS-986419

EXPERIMENTAL

Drug: [14C]BMS-986419

Interventions

[14C]BMS-986419 DRUG

Specified dose on specified days

Also known as: BMS-986419, EOAI4018683

[14C]BMS-986419

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, 53704-2526, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 6, 2023
• Study Start: May 5, 2023
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)