A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05445440
Collaborator
(none)
32
2
6.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine
Anticipated Study Start Date :
Jul 18, 2022
Anticipated Primary Completion Date :
Jan 26, 2023
Anticipated Study Completion Date :
Jan 26, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Part 1

Drug: Methotrexate
Specified dose on specified days

Drug: Leucovorin
Specified dose on specified days

Drug: BMS-986371
Specified dose on specified days
Other Names:
  • CC-99677
  • Experimental: Part 2

    Drug: Methotrexate
    Specified dose on specified days

    Drug: Leucovorin
    Specified dose on specified days

    Drug: BMS-986371
    Specified dose on specified days
    Other Names:
  • CC-99677
  • Drug: Sulfasalazine
    Specified dose on specified days

    Outcome Measures

    Primary Outcome Measures

    1. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) [Up to 22 days]

      Part 1

    2. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF]) [Up to 22 days]

      Part 1

    3. Maximum observed plasma concentration (Cmax) [Up to 22 days]

      Part 1

    Secondary Outcome Measures

    1. AUC(0-T) [Up to 22 days]

      Part 2

    2. AUC(INF) [Up to 22 days]

      Part 2

    3. Cmax [Up to 22 days]

      Part 2

    4. Number of participants with adverse events (AEs) [Up to 30 days post participant's last study treatment]

      Parts 1 and 2

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol

    • Body mass index of 18 to 32 kg/m^2, inclusive

    Exclusion Criteria:
    • Any significant acute or chronic medical illness

    • Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug

    • Any other medical, psychiatric and/or social reason as determined by the Investigator

    Other protocol-defined inclusion/exclusion criteria apply

    Contacts and Locations

    Locations

    No locations specified.

    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:
    NCT05445440
    Other Study ID Numbers:
    • IM046-003
    First Posted:
    Jul 6, 2022
    Last Update Posted:
    Jul 6, 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:

    Study Results

    No Results Posted as of Jul 6, 2022