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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Liver Disease

Intervention / Treatment
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* Drug: naproxcinod


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>750 mg naproxcinod | Drug: naproxcinod<br>* 750 mg bid<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatic impairment