A Study to Assess the Effect of Multiple Doses of Gemfribozil on a Single Dose of ASP3652, and to Assess the Effects of Multiple Doses of ASP3652 on a Single Dose of Repaglinide in the Body of Healthy Subjects
An Open Label, Drug-drug Interaction Study to Assess the Effect of Multiple Doses of Gemfibrozil on the Single Dose Pharmacokinetics of ASP3652 and to Assess the Effect of Multiple Doses of ASP3652 on the Single Dose Pharmacokinetics of Repaglinide
Sponsor: Astellas Pharma Europe B.V.
This PHASE1 trial investigates Drug-Drug Interaction (DDI) and Healthy Subjects and is currently completed. Astellas Pharma Europe B.V. leads this study, which shows 6 recorded versions since 2012 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)Part 1:
On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.
Part 2:
On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.
Part 1:
On Day 1, a single dose of ASP3652 is administered. After a wash-out period of 3 days, bid (twice daily) dosing of gemfibrozil starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of gemfibrozil administration), a single dose of ASP3652 is administered one hour after the morning dose of gemfibrozil.
Part 2:
On Day 1, a single dose of repaglinide is administered. After a wash-out period of 3 days, bid dosing of ASP3652 starts on Day 4 and continues for 7 days until Day 10. On Day 8 (the 5th day of ASP3652 administration), a single dose of repaglinide is administered one hour after the morning dose of ASP3652.
Status Flow
Change History
6 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1
-
Sep 2024 — Present [monthly]
Completed PHASE1
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE1
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE1
-
Feb 2017 — Jan 2021 [monthly]
Completed PHASE1
▶ Show 1 earlier version
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE1
First recorded
Apr 2012
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Astellas Pharma Europe B.V.
For direct contact, visit the study record on ClinicalTrials.gov .