Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Miami, Florida


Purpose:

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


Study summary:

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.


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


NCT ID:

NCT00621881


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Miami, Florida
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.