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

To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

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.

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.