A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects

A Phase 1, Repeated-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750 mg Bid Administered to Patients With Impaired Hepatic Function Compared to Matching Healthy Subjects

This is an open-label study that will compare the pharmacokinetic and safety effects of naproxcinod in hepatic impaired patients vs. matching healthy subjects.

This is an open-label, non-randomized, parallel-group study that will be conducted at two study sites. Patients with hepatic impairment and matched healthy subjects will receive naproxcinod 750 mg bid for 6 days and qd for the last day.

Inclusion Criteria:

• Male or Female, age 40 to 75 years with stable hepatic insufficiency conforming to Child-Pugh classification B OR
• Male or Female, age 40 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria:

• Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except lose dose aspirin
• History of renal impairment
• Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
• Clinically relevant abnormal ECG
• Alcohol or drug abuse within the last 6 months
• Any significant or chronic disease (except hepatic insufficiency for the patient cohort) which may interfere with study evaluations