Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2026-06-06 @ 9:46 PM
Study NCT ID:
NCT04070495
Status:
COMPLETED
Last Update Posted:
2019-11-29
First Post:
2019-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin
Sponsor:
Kyowa Kirin Co., Ltd.
Organization:
Study Overview
Official Title:
A Drug Interaction Study of KW-6356 and Clarithromycin or Rifampicin (A Drug Interaction Study With a CYP3A4/5 Inhibitor or Inducer)
Status:
COMPLETED
Status Verified Date:
2019-11
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:
The purpose of this study is to investigate the effects of CYP3A4/5 inhibitor or inducer on the pharmacokinetics of KW-6356 when CYP3A4/5 inhibitor or inducer is orally administered to healthy Japanese men for 7 days.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: