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Completed

NCT Number: NCT06088264

A Study to Evaluate the Drug Levels, Metabolism, and Removal of BMS-986322 in Healthy Adult Male Participants

The purpose of this study is to evaluate the drug levels, metabolism, and removal of BMS-986322 in healthy adult male participants.

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Key information

Conditions

Healthy Male Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must have a body mass index of 18.0 to 32.0 kg/m2, inclusive.
  • Participants will be required to always use a latex or other synthetic condom with spermicide during any sexual activity
  • Participants must refrain from donating sperm during the entire study and for at least 90 days from dose of study drug.

Exclusion criteria

  • Participant must not have had any clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months prior to admission to the clinic.
  • Participant must not be currently employed in a job requiring radiation exposure monitoring.
  • Participant must not have had any major surgery within 4 weeks of study drug administration that could impact upon the absorption of study drug

Treatment and study plan

BMS-986322

Drug

Specified dose on specified days.

Primary outcomes

  1. Maximum observed in plasma/whole blood concentration (Cmax)

    Time frame: Up to day 17

  2. Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Time frame: Up to day 17

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

    Time frame: Up to day 17

  4. Time of maximum observed in plasma/whole blood concentration (T-max)

    Time frame: Up to day 17

  5. Terminal elimination half-life (T-HALF)

    Time frame: Up to day 17

  6. Apparent total body clearance (CL/F)

    Time frame: Up to day 17

  7. Apparent volume of distribution of terminal phase (Vz/F)

    Time frame: Up to day 17

  8. Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))

    Time frame: Up to day 17

  9. Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)

    Time frame: Up to day 17

  10. Total amount of radioactivity recovered in urine (UR)

    Time frame: Up to day 17

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

    Time frame: Up to day 17

  12. Total amount of radioactivity recovered in feces (FR)

    Time frame: Up to day 17

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

    Time frame: Up to day 17

  14. Total amount of radioactivity recovered in urine and feces combined (RTotal)

    Time frame: Up to day 17

  15. Percent of total amount of radioactivity recovered in all excreta (%Total)

    Time frame: Up to day 17

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to day 47

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to day 47

  3. Number of participants with AEs leading to discontinuation

    Time frame: Up to day 47

  4. Number of participants with vital sign abnormalities

    Time frame: Up to day 17

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to day 17

  6. Number of participants with clinically significant physical examination findings

    Time frame: Up to day 17

  7. Number of participants with clinical laboratory abnormalities

    Time frame: Up to day 17

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986322 in Healthy Adult Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 18, 2023
Registry last updated
Mar 29, 2024

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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