Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT02961660
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2016-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
Sponsor:
Janssen Research & Development, LLC
Organization:
Study Overview
Official Title:
An Open-label Study to Evaluate the Effect of Severe Renal Impairment on the Single-dose Pharmacokinetics of Odalasvir
Status:
COMPLETED
Status Verified Date:
2025-01
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:
The main purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of odalasvir (ODV) in participants with severe renal impairment and compare with the PK in matched participants with normal renal function.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 64294178HPC1014 | OTHER | Janssen Research & Development, LLC | View |