Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects

NCT07196449 ↗

Phase 1 Active not recruiting 12 enrolled Seoul National University Bundang Hospital

RandomizedCrossoverOpen-labelPrevention

Summary

This study will evaluate how methotrexate is processed in the body when given with low doses of rifampicin or cyclosporine. These drugs may affect how methotrexate is absorbed and cleared, which could change its safety and effectiveness. Healthy volunteers will receive methotrexate with either rifampicin or cyclosporine, and blood samples will be collected to measure drug levels. The findings may help identify possible drug interactions and improve the safe use of methotrexate.

Timeline

Start: 2025-05-14
Primary completion: 2025-06-09
Completion: 2026-04-14

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclosporine	Peptide	100 mg	—
Subject	Methotrexate	Small molecule	2.5 mg	—
Subject	Rifampin	Small molecule	150 mg	—
Subject	Rifampin	Small molecule	300 mg	—

Indications

No indication recorded.