Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT00674856
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2008-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Sponsor:
NicOx
Organization:
Study Overview
Official Title:
A Phase 1 Repeated Dose Open Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750mg Bid Administered to Patients With Impaired Renal Function Compared to Matching Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2009-01
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:
HCT3012-X-106
Brief Summary:
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
Detailed Description:
This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.
Study Oversight
Has Oversight DMC:
True
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?: