NCT01754805

A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis

A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Subjects With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A drug interaction study to evaluate the effect of ASP015K (twice daily) on the pharmacokinetics (PK) of once weekly oral methotrexate (MTX).

Detailed description

Patients check in on day -1 and remain confined until all the exit procedures are performed on the morning of day 10. Patients to return for 1 post-treatment follow-up visit on day 13. Patients receive a single dose of methotrexate on day 1 and day 8 and ASP015K (twice daily) on days 3 through 8 plus the morning of day 9.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	peficitinib	oral
DRUG	methotrexate	oral

Timeline

• Start date: 2010-01-22
• Primary completion: 2010-03-25
• Completion: 2010-03-25
• First posted: 2012-12-21
• Last updated: 2024-10-21

Locations

1 site across 1 country: United States