A Study to Assess the Bioavailability of ASP015K
A Phase 1, Open-Label, 4-Way Crossover Regional Drug Absorption Study to Assess the Bioavailability of ASP015K in Healthy Subjects
Sponsor: Astellas Pharma Inc
Listed as NCT01430078, this PHASE1 trial focuses on Healthy and remains completed. Sponsored by Astellas Pharma Inc, it has been updated 6 times since 2010, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
Each subject will participate in four separate study periods. In each period, subjects will be admitted to the clinical unit approximately seven hours on the day prior to being given study drug. Subjects will remain at the clinical research unit for the next 24 hours after they have received study drug. Subjects will return to the clinical research unit at 36 and 48 hours after they have received study drug to give blood samples. There will be a minimum of a four day "washout" period, between each study period.
Under certain circumstances, subjects may be asked to return to the clinical research unit for an additional study period.
Status Flow
Change History
6 versions recorded-
Sep 2024 — Present [monthly]
Completed PHASE1
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE1
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Sep 2010
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Astellas Pharma Inc
For direct contact, visit the study record on ClinicalTrials.gov .