Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02947711
Status:
COMPLETED
Last Update Posted:
2017-03-07
First Post:
2016-10-26
Brief Title:
Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-label Single-Sequence Drug-Drug Interaction Study to Evaluate the Effect of Diltiazem Extended Release on the Pharmacokinetics of E2027 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This Phase 1 open-label single-sequence drug-drug Interaction study is conducted to evaluate the effect of diltiazem extended release ER a moderate CYP3A inhibitor and P glycoprotein Pgp inhibitor on the pharmacokinetics PK of a single oral dose of E2027 in healthy participants
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None