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

NicOx

Status and phase

Completed

Phase 1

Conditions

Liver Disease

Treatments

Drug: naproxcinod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00621881

HCT3012-X-105

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

Accepts Healthy Volunteers

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