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OpenTrials
Completed

NCT Number: NCT05981963

A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

The purpose of this study is to evaluate the excretion pathway of orally administered [14C]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.

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Key information

Conditions

Healthy Male 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

  • Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
  • Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and total body weight ≥ 50 kg

Exclusion criteria

  • Any significant acute or chronic medical illness as determined by the investigator.
  • A history of clinically significant hepatic or pancreatic disease.
  • Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.

Note: Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

[14C]-BMS-986196

Drug

Specified dose on specified days

Other names: BMS-986196

Primary outcomes

  1. Total Radioactivity (TRA): Maximum observed plasma concentration (Cmax)

    Time frame: Up to Day 15

  2. TRA: Time of Cmax (Tmax)

    Time frame: Up to Day 15

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

    Time frame: Up to Day 15

  4. TRA: Amount of radioactivity recovered in urine (UR)

    Time frame: Up to Day 15

  5. TRA: Amount of radioactivity recovered in feces (FR)

    Time frame: Up to Day 15

  6. TRA: Amount of radioactivity recovered in bile (BR)

    Time frame: Up to 14 hours post dose

  7. TRA: Percent of administered dose recovered in urine (%UR)

    Time frame: Up to Day 15

  8. TRA: Percent of administered dose recovered in feces (%FR)

    Time frame: Up to Day 15

  9. TRA: Total percent of administered dose recovered (urine, feces, and bile combined) (% Total)

    Time frame: Up to Day 15

Secondary outcomes

  1. Cmax

    Time frame: Up to Day 15

  2. Tmax

    Time frame: Up to Day 15

  3. AUC (0-T)

    Time frame: Up to Day 15

  4. Number of Participants with Adverse Events (AEs)

    Time frame: Up to Day 29

  5. Number of Participants with Serious AEs (SAEs)

    Time frame: Up to Day 29

  6. Number of Participants with AEs Leading to Discontinuation

    Time frame: Up to Day 29

  7. Number of Participants with Vital Sign Abnormalities

    Time frame: Up to Day 15

  8. Number of Participants with Electrocardiogram (ECG) Abnormalities

    Time frame: Up to Day 15

  9. Number of Participants with Physical Examination Abnormalities

    Time frame: Up to Day 15

  10. Number of Participants with Clinical Laboratory Abnormalities

    Time frame: Up to Day 15

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 Orally Administered 60 mg BMS-986196, Including Radioactively Labeled [14C]-BMS-986196, in Healthy Male Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 8, 2023
Registry last updated
Nov 13, 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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