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

Phase 1

Completed

• Conditions: Renal Failure
• Interventions: Drug: naproxcinod

• Registration Number: NCT00674856
• Lead Sponsor: NicOx

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-07
• Study First Posted: 2008-05-08
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-27
• Last Update Posted: 2009-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
• Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria

• Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
• A history of alcohol or drug abuse.
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
• Clinically relevant abnormal ECG
• Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
• Participation within 30 days prior to screening in another investigational study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
naproxcinod	naproxcinod	naproxcinod 750mg(375mg caps x2), administered twice a day.

Primary Outcome Measures

Name	Time	Method
To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.	8 days

Secondary Outcome Measures

Name	Time	Method
To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.	8 days
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.	8 days