Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-13 @ 5:23 PM
Study NCT ID:
NCT01754805
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study to Evaluate the Pharmacokinetics of ASP015K and Methotrexate in Patients With Rheumatoid Arthritis
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: