Study to Assess the Way the Body Absorbs, Distributes, Breaks Down and Eliminates Radioactive BMS-986278 in Healthy Male Participants

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04567667
Collaborator
(none)
9
1
2
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Study Details

Study Description

Brief Summary

The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics and Metabolism of [14C] BMS-986278 in Healthy Male Participants
Actual Study Start Date :
Oct 15, 2020
Actual Primary Completion Date :
Apr 11, 2021
Actual Study Completion Date :
Apr 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

Drug: [14C] BMS-986278
Specified dose on specified days

Experimental: Group 2

Drug: [14C] BMS-986278
Specified dose on specified days

Drug: Kinevac®
Specified dose on specified days
Other Names:
  • Sincalide
  • Outcome Measures

    Primary Outcome Measures

    1. Maximum observed plasma concentration (Cmax) of BMS-986278 [Up to 15 days]

    2. Maximum observed plasma concentration (Cmax) of total radioactivity (TRA) [Up to 15 days]

    3. Time of maximum observed plasma concentration (Tmax) of BMS-986278 [Up to 15 days]

    4. Time of maximum observed plasma concentration (Tmax) of TRA [Up to 15 days]

    5. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of BMS-986278 [Up to 15 days]

    6. Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) of TRA [Up to 15 days]

    Secondary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to 15 days]

    2. Incidence of Serious Adverse Events (AEs) [Up to 73 days]

    3. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 43 days]

    4. Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests [Up to 43 days]

    5. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 43 days]

    6. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 43 days]

    7. Incidence of clinically significant changes in vital signs: Heart rate [Up to 43 days]

    8. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 43 days]

    9. Incidence of clinically significant changes in vital signs: Body temperature [Up to 43 days]

    10. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF [Up to 43 days]

      QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave.

    11. Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval [Up to 43 days]

      The QT interval is the time from the start of the Q wave to the end of the T wave.

    12. Incidence of clinically significant changes in physical examination findings [Up to 43 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes

    For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

    Inclusion Criteria:
    • No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), vital signs, and clinical laboratory determinations

    • Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, and total body weight ≥50 kg (110 lb), at screening. BMI = weight (kg)/(height [m])2

    • Males must agree to follow specific methods of contraception, if applicable

    Exclusion Criteria:
    • Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome

    • Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could impact upon the absorption of study treatment

    • Any major surgery within 6 weeks of study treatment administration

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance - Clinical Pharmacology Services - Madison Madison Wisconsin United States 53704

    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:
    NCT04567667
    Other Study ID Numbers:
    • IM027-048
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Jun 2, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Bristol-Myers Squibb

    Study Results

    No Results Posted as of Jun 2, 2022