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Completed

NCT Number: NCT05409157

A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

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 as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
  • Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion criteria

  • Any significant acute or chronic medical illness
  • Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
  • History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

BMS-986166

Drug

Specified dose on specified days

Bisacodyl

Drug

Specified dose on specified days

Other names: Dulcolax®

Primary outcomes

  1. Total amount of total radioactivity (TRA) recovered in urine (UR)

    Time frame: Up to 90 days

  2. Total amount of TRA recovered in feces (FR)

    Time frame: Up to 90 days

  3. Total amount of TRA recovered in urine and feces combined (RTotal)

    Time frame: Up to 90 days

  4. Percent of TRA recovered in urine (%UR)

    Time frame: Up to 90 days

  5. Percent of TRA recovered in feces (%FR)

    Time frame: Up to 90 days

  6. Percent of TRA recovered in urine and feces combined (%TOTAL)

    Time frame: Up to 90 days

  7. Maximum observed concentration (Cmax)

    Time frame: Up to 89 days

  8. Time of maximum observed concentration (Tmax)

    Time frame: Up to 89 days

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

    Time frame: Up to 89 days

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 124 days

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

    Time frame: Up to 124 days

  3. Number of participants with vital sign abnormalities

    Time frame: Up to 90 days

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 90 days

  5. Number of participants with physical examination abnormalities

    Time frame: Up to 90 days

  6. Number of participants with clinical laboratory test abnormalities

    Time frame: Up to 90 days

  7. Maximum observed concentration (Cmax)

    Time frame: Up to 89 days

  8. Time of maximum observed concentration (Tmax)

    Time frame: Up to 89 days

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

    Time frame: Up to 89 days

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-986166 in Healthy Male Participants

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 8, 2022
Registry last updated
Mar 22, 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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