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

Completed · Phase 1

Conditions studied: Liver Disease

In brief

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

Key facts

Study ID

NCT00621881

Run by

NicOx

People needed

24

Starts

2008-01-01

Last updated by the study team

2011-06-17

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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