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A Study to Assess the Levels in Blood Plasma of BMS-986278 in Healthy Participants Following Administration of Tablets, With or Without Food, and in the Presence of an Antacid (Esomeprazole)

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Completed
CT.gov ID
NCT04468815
Collaborator
(none)
24
Enrollment
1
Location
4
Arms
2.9
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess levels in blood plasma of BMS-986278 and the food effect in healthy participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-Label Study to Assess Relative Bioavailability, Food Effect, and Esomeprazole Drug-Drug Interaction of BMS-986278 Tablets Following a Single Dose Administration in Healthy Participants
Actual Study Start Date :
Jul 10, 2020
Actual Primary Completion Date :
Oct 7, 2020
Actual Study Completion Date :
Oct 7, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment A: BMS-986278 suspension, fasted

Drug: BMS-986278 suspension
Specified dose on specified days
Experimental: Treatment B: BMS-986278 tablet, fasted

Drug: BMS-986278 Tablet
Specified dose on specified days
Experimental: Treatment C: BMS-986278 tablet, fed

Drug: BMS-986278 Tablet
Specified dose on specified days
Experimental: Treatment D: BMS-986278 tablet + esomeprazole capsule, fasted

Drug: BMS-986278 Tablet
Specified dose on specified days

Drug: Esomeprazole
Specified dose on specified days
Other Names:
  • NEXIUM

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum plasma concentration (Cmax) of BMS-986278 [Up to 5 days]

    2. Area under the concentration-time curve from time 0 (dosing) to the time of the last quantifiable concentration observed (AUC(0-T) of BMS-986278 [Up to 5 days]

    3. Area under the concentration-time curve from time 0 (dosing) extrapolated to infinity AUC (INF) of BMS-986278 from the respective test treatments [Up to 5 days]

    Secondary Outcome Measures

    1. Incidence of Adverse Events (AEs) [Up to 29 days]

    2. Incidence of Serious Adverse (SAE's) [Up to 57 days]

    3. Incidence of AEs leading to discontinuation [Up to 29 days]

    4. Incidence of clinically significant changes in vital signs: Blood pressure [Up to 48 days]

    5. Incidence of clinically significant changes in vital signs: Heart rate [Up to 48 days]

    6. Incidence of clinically significant changes in vital signs: Respiratory rate [Up to 48 days]

    7. Incidence of clinically significant changes in vital signs: Body temperature [Up to 48 days]

    8. Incidence of clinically significant changes in electrocardiogram (ECG) parameters [Up to 48 days]

    9. Incidence of clinically significant changes in physical examination findings [Up to 48 days]

    10. Incidence of clinically significant changes in clinical laboratory results: Clinical chemistry tests [Up to 48 days]

    11. Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests [Up to 48 days]

    12. Incidence of clinically significant changes in clinical laboratory results: Hematology tests [Up to 48 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Healthy participants, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations in the opinion of the investigator

    • Women and men must agree to follow specific methods of contraception

    Exclusion Criteria:

    • Women of childbearing potential (WOCBP) and Women who are pregnant or breastfeeding

    • 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

    • Exposure to any investigational drug or placebo within 4 weeks of first study treatment administration.

    • History of any significant drug and/or food allergies (such as anaphylaxis or hepatotoxicity)

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ICON (LPRA) - Salt Lake Salt Lake City Utah United States 84124

    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:
    NCT04468815
    Other Study ID Numbers:
    • IM027-054
    First Posted:
    Jul 13, 2020
    Last Update Posted:
    May 10, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Esomeprazole

    Study Results

    No Results Posted as of May 10, 2022