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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05409157
Collaborator
(none)
8
Enrollment
1
Location
1
Arm
1.4
Anticipated Duration (Months)
5.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
8 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Single-center, Open-label Study to Evaluate the Pharmacokinetics, Metabolism, and Excretion of [14C] BMS-986166 in Healthy Male Participants
Anticipated Study Start Date :
Jun 17, 2022
Anticipated Primary Completion Date :
Jul 29, 2022
Anticipated Study Completion Date :
Jul 29, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group 1: BMS-986166

Drug: BMS-986166
Specified dose on specified days

Drug: Bisacodyl
Specified dose on specified days
Other Names:
  • Dulcolax®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Total amount of total radioactivity (TRA) recovered in urine (UR) [Up to 90 days]

    2. Total amount of TRA recovered in feces (FR) [Up to 90 days]

    3. Total amount of TRA recovered in urine and feces combined (RTotal) [Up to 90 days]

    4. Percent of TRA recovered in urine (%UR) [Up to 90 days]

    5. Percent of TRA recovered in feces (%FR) [Up to 90 days]

    6. Percent of TRA recovered in urine and feces combined (%TOTAL) [Up to 90 days]

    7. Maximum observed concentration (Cmax) [Up to 89 days]

    8. Time of maximum observed concentration (Tmax) [Up to 89 days]

    9. Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [Up to 89 days]

    Secondary Outcome Measures

    1. Number of participants with adverse events (AEs) [Up to 124 days]

    2. Number of participants with serious adverse events (SAEs) [Up to 124 days]

    3. Number of participants with vital sign abnormalities [Up to 90 days]

    4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 90 days]

    5. Number of participants with physical examination abnormalities [Up to 90 days]

    6. Number of participants with clinical laboratory test abnormalities [Up to 90 days]

    7. Maximum observed concentration (Cmax) [Up to 89 days]

    8. Time of maximum observed concentration (Tmax) [Up to 89 days]

    9. Area under the concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)] [Up to 89 days]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Labcorp Clinical Research Unit - Madison Madison Wisconsin United States 53704-2526

    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:
    NCT05409157
    Other Study ID Numbers:
    • IM018-010
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bisacodyl

    Study Results

    No Results Posted as of Jun 8, 2022