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Completed

NCT Number: NCT05847439

A Study to Evaluate 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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, 53704-2526, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]BMS-986419

Drug

Specified dose on specified days

Other names: BMS-986419, EOAI4018683

Primary outcomes

  1. Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 20

  2. Time of maximum plasma observed concentration (Tmax)

    Time frame: Up to Day 20

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

    Time frame: Up to Day 20

  4. Total radioactivity recovered in urine (UR)

    Time frame: Up to Day 30

  5. Total radioactivity recovered in feces (FR)

    Time frame: Up to Day 30

  6. Total radioactivity recovered in bile (BR)

    Time frame: Up to Day 30

  7. Total radioactivity recovered (Rtotal)

    Time frame: Up to Day 30

  8. Percent of total radioactivity recovered (%Total)

    Time frame: Up to Day 30

  9. Percent of total radioactivity recovered in urine (%UR)

    Time frame: Up to Day 30

  10. Percent of total radioactivity recovered in feces (%FR)

    Time frame: Up to Day 30

Secondary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 60

  2. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to Day 60

  3. Number of Participants with AEs leading to discontinuation

    Time frame: Up to Day 60

  4. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 30

  5. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 30

  6. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 30

  7. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 30

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 6, 2023
Registry last updated
Oct 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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