Status:
COMPLETED
A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects
Lead Sponsor:
NicOx
Conditions:
Liver Disease
Eligibility:
All Genders
40-75 years
Phase:
PHASE1
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00621881
Start Date
January 1 2008
Last Update
June 17 2011
Active Locations (1)
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1
Miami, Florida, United States