Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06529796
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-26
Brief Title:
Evaluation of the Pharmacokinetics and Safety of Inaxaplin in Participants With Mild or Moderate Hepatic Impairment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Open-label Study to Assess the Pharmacokinetics and Safety of a Single Dose of Inaxaplin in Subjects With Mild or Moderate Hepatic Impairment and in Matched Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this study is to evaluate the pharmacokinetics safety and tolerability of Inaxaplin IXP in participants with mild or moderate hepatic impairment and in matched healthy participants
Detailed Description:
This clinical trial information was submitted voluntarily under the applicable law and therefore certain submission deadlines may not apply That is clinical trial information for this applicable clinical trial was submitted under section 402j4A of the Public Health Service Act and 42 CFR 1160 and is not subject to the deadlines established by sections 402j2 and 3 of the Public Health Service Act or 42 CFR 1124 and 1144
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