NCT00621881CompletedPhase 1
A Phase 1, Repeated-Dose, Open-Label Study to Investigate the Pharmacokinetics and Safety of Naproxcinod 750 mg Bid Administered to Patients With Impaired Hepatic Function Compared to Matching Healthy Subjects
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- NicOx
- Enrollment
- 24
- Primary Endpoint
- To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
Study Overview
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 for 6 days and qd for the last day.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
1
Experimental
750 mg naproxcinod
Intervention: naproxcinod (Drug)
Outcomes
Primary Outcomes
To assess the pharmacokinetics of naproxcinod and its metabolites after repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patient in comparison with matching healthy subjects
Time Frame: 8 days
Secondary Outcomes
- To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects.(8 days)
Investigators
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