Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562946
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
The Study to Assess the Pharmacokinetics of Pimicotinib in Subjects with Mild and Moderate Hepatic Impairment Relative to Subjects with Normal Hepatic Function
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Parallel-Group Single-Dose Study to Assess the Pharmacokinetics of Pimicotinib in Subjects with Mild and Moderate Hepatic Impairment Relative to Subjects with Normal Hepatic Function
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 1 open-label parallel-group single-center study to evaluate the pharmacokinetics and safety of a single 25 mg oral dose of pimicotinib in subjects with mild and moderate hepatic impairment and in control subjects with normal hepatic function
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