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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

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.

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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.

Conditions

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Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1

750 mg naproxcinod

Group Type EXPERIMENTAL

naproxcinod

Intervention Type DRUG

750 mg bid

Interventions

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naproxcinod

750 mg bid

Intervention Type DRUG

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes