A Study to Assess the Effects of BMS-986371 on the Drug Levels of Methotrexate in the Presence and Absence of Sulfasalazine
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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2022
CompletedFirst Posted
Study publicly available on registry
July 6, 2022
CompletedStudy Start
First participant enrolled
September 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2022
CompletedFebruary 8, 2023
February 1, 2023
2 months
June 30, 2022
February 6, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Part 1
Up to 22 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Part 1
Up to 22 days
Maximum observed plasma concentration (Cmax)
Part 1
Up to 22 days
Secondary Outcomes (4)
AUC(0-T)
Up to 22 days
AUC(INF)
Up to 22 days
Cmax
Up to 22 days
Number of participants with adverse events (AEs)
Up to 30 days post participant's last study treatment
Study Arms (2)
Part 1
EXPERIMENTALPart 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quotient Sciences Miami
Miami, Florida, 33126, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2022
First Posted
July 6, 2022
Study Start
September 6, 2022
Primary Completion
November 17, 2022
Study Completion
November 23, 2022
Last Updated
February 8, 2023
Record last verified: 2023-02