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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NicOx
• Treatments: Naproxen; Naproxen-n-butyl nitrate

Criteria

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