Ignite Creation Date:
2024-05-06 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03664544
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2018-08-27
Brief Title:
PK Study in Subjects With Severe Hepatic Impairment
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Organization:
Mitsubishi Tanabe Pharma Corporation
Study Overview
Official Title:
An Open-Label Single-Dose Study to Evaluate the Pharmacokinetics of MCI-186 in Subjects With Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Status:
COMPLETED
Status Verified Date:
2023-04
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:
MCI-186-E05 HP
Brief Summary:
This is an open-label single-dose study in male and female subjects with severe hepatic impairment and in male and female subjects with normal hepatic function
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-001163-23 | EUDRACT_NUMBER | None | None |