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

Sponsored by:	NicOx
Information provided by:	NicOx
ClinicalTrials.gov Identifier:	NCT00621881

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.

Condition	Intervention	Phase
Liver Disease	Drug: naproxcinod	Phase I

MedlinePlus related topics: Liver Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	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

Further study details as provided by NicOx:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess safety and tolerability of repeated 750 mg bid oral administration of naproxcinod in hepatic impaired patients in comparison with matching healthy subjects. [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	January 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 750 mg naproxcinod	Drug: naproxcinod 750 mg bid

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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621881

Locations

United States, Florida

Miami, Florida, United States

Sponsors and Collaborators

NicOx

More Information

Responsible Party:	( NicOx )
Study ID Numbers:	HCT3012-X-105
Study First Received:	February 12, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00621881
Health Authority:	United States: Food and Drug Administration

Keywords provided by NicOx:

hepatic impairment

Study placed in the following topic categories:

Nitric Oxide
Liver Diseases
Naproxen

Digestive System Diseases
Naproxen-n-butyl nitrate
Healthy

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Cardiovascular Agents
Pharmacologic Actions
Nitric Oxide Donors

ClinicalTrials.gov processed this record on January 16, 2009