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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05847439
Collaborator
(none)
8
Enrollment
1
Arm
1.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Single-center, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]BMS-986419 in Healthy Male Participants
Anticipated Study Start Date :
May 8, 2023
Anticipated Primary Completion Date :
Jul 5, 2023
Anticipated Study Completion Date :
Jul 5, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: [14C]BMS-986419

Drug: [14C]BMS-986419
Specified dose on specified days
Other Names:
  • BMS-986419
  • EOAI4018683

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) [Up to Day 20]

    2. Time of maximum plasma observed concentration (Tmax) [Up to Day 20]

    3. Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T]) [Up to Day 20]

    4. Total radioactivity recovered in urine (UR) [Up to Day 30]

    5. Total radioactivity recovered in feces (FR) [Up to Day 30]

    6. Total radioactivity recovered in bile (BR) [Up to Day 30]

    7. Total radioactivity recovered (Rtotal) [Up to Day 30]

    8. Percent of total radioactivity recovered (%Total) [Up to Day 30]

    9. Percent of total radioactivity recovered in urine (%UR) [Up to Day 30]

    10. Percent of total radioactivity recovered in feces (%FR) [Up to Day 30]

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events (AEs) [Up to Day 60]

    2. Number of Participants with Serious AEs (SAEs) [Up to Day 60]

    3. Number of Participants with AEs leading to discontinuation [Up to Day 60]

    4. Number of Participants with Vital Sign Abnormalities [Up to Day 30]

    5. Number of Participants with Electrocardiogram (ECG) Abnormalities [Up to Day 30]

    6. Number of Participants with Physical Examination Abnormalities [Up to Day 30]

    7. Number of Participants with Clinical Laboratory Abnormalities [Up to Day 30]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bristol-Myers Squibb

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Bristol-Myers Squibb
    ClinicalTrials.gov Identifier:
    NCT05847439
    Other Study ID Numbers:
    • CN007-1004
    First Posted:
    May 6, 2023
    Last Update Posted:
    May 6, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb
    Pharmacokinetics
    Metabolite profile
    Radioactivity
    BMS-986419
    Healthy volunteer
    Healthy participants

    Study Results

    No Results Posted as of May 6, 2023