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Completed

NCT Number: NCT05445440

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences Miami

Miami, Florida, 33126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

Specified dose on specified days

Leucovorin

Drug

Specified dose on specified days

BMS-986371

Drug

Specified dose on specified days

Other names: CC-99677

Sulfasalazine

Drug

Specified dose on specified days

Primary outcomes

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

    Time frame: Up to 22 days

    Part 1

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

    Time frame: Up to 22 days

    Part 1

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 22 days

    Part 1

Secondary outcomes

  1. AUC(0-T)

    Time frame: Up to 22 days

    Part 2

  2. AUC(INF)

    Time frame: Up to 22 days

    Part 2

  3. Cmax

    Time frame: Up to 22 days

    Part 2

  4. Number of participants with adverse events (AEs)

    Time frame: Up to 30 days post participant's last study treatment

    Parts 1 and 2

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 6, 2022
Registry last updated
Feb 8, 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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