Ignite Creation Date:
2025-12-18 @ 8:19 AM
Ignite Modification Date:
2025-12-23 @ 9:02 PM
Study NCT ID:
NCT04332523
Status:
None
Last Update Posted:
2022-06-13 00:00:00
First Post:
2020-04-01 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of JNJ-53718678 in Participants With Hepatic Impairment
Sponsor:
None
Organization:
Study Overview
Official Title:
A Single-Dose, Open-Label, Parallel-Group Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on the Pharmacokinetics of JNJ-53718678
Status:
None
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
A strategic decision was made to discontinue the study. The decision was not based on a safety concern.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of the study is to evaluate the pharmacokinetc (PK) of a single oral dose of JNJ-53718678 in participants with varying degrees of impaired hepatic function (mild, moderate, and severe) when compared with participants 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?: