A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis
A drug interaction study to evaluate the effect of ASP015K (twice daily) on the pharmacokinetics (PK) of once weekly oral methotrexate (MTX).
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Phase 1b, Open-Label, Single Sequence, Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis|
- Pharmacokinetics of methotrexate (MTX): Area under the concentration-time curve from time of dosing to infinity (AUCinf) [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]
- Pharmacokinetics of methotrexate (MTX): Maximum concentration (Cmax) [ Time Frame: Days 1 and 8 ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
|Experimental: ASP015K and methotrexate||
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754805
|United States, Alabama|
|Anniston, Alabama, United States, 36207|
|Study Chair:||Central Contact||Astellas Pharma Global Development|