NCT00674856

A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: NicOx · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Failure

Interventions

Type	Name	Description
DRUG	naproxcinod	750mg

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-09-01
• Completion: 2008-10-01
• First posted: 2008-05-08
• Last updated: 2009-01-28

Locations

3 sites across 1 country: United States