Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752540
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-02-11
Brief Title:
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Sponsor:
F2G Biotech GmbH
Organization:
F2G Biotech GmbH
Study Overview
Official Title:
A Phase I Single-dose Parallel Group Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
Status:
COMPLETED
Status Verified Date:
2022-03
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:
A single oral dose study to investigate the PK and safety of olorofim in mild and moderately hepatically impaired subjects compared to 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