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

Healthy Participants Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05445440
• Other study ID #: IM046-003
• Status: Completed
• Phase: Phase 1
• Start date: September 6, 2022
• Est. completion date: November 23, 2022

Study information

• Verified date: February 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 23, 2022
• Est. primary completion date: November 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Methotrexate
Specified dose on specified days
• Leucovorin
Specified dose on specified days
• BMS-986371
Specified dose on specified days
• Sulfasalazine
Specified dose on specified days

Locations

Country	Name	City	State
United States	Quotient Sciences Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])	Part 1	Up to 22 days
Primary	Maximum observed plasma concentration (Cmax)	Part 1	Up to 22 days
Secondary	AUC(0-T)	Part 2	Up to 22 days
Secondary	AUC(INF)	Part 2	Up to 22 days
Secondary	Cmax	Part 2	Up to 22 days
Secondary	Number of participants with adverse events (AEs)	Parts 1 and 2	Up to 30 days post participant's last study treatment

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting