NCT05445440

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Methotrexate	Specified dose on specified days
DRUG	Leucovorin	Specified dose on specified days
DRUG	BMS-986371	Specified dose on specified days
DRUG	Sulfasalazine	Specified dose on specified days

Timeline

• Start date: 2022-09-06
• Primary completion: 2022-11-17
• Completion: 2022-11-23
• First posted: 2022-07-06
• Last updated: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study