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

Phase 1

Completed

• Conditions: Liver Disease
• Interventions: Drug: naproxcinod

• Registration Number: NCT00621881
• Lead Sponsor: NicOx

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2008-04
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	naproxcinod	750 mg naproxcinod

Primary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects	8 days

Secondary Outcome Measures

Name	Time	Method
To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.	8 days