A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-10-31

Brief Summary

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To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function

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Detailed Description

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This is an 8-day, repeated dose, open label study to investigate the pharmacokinetics and safety of naproxcinod in order to guide initial dosing and achieve the optimal dose of naproxcinod in Renal impaired patients.

Conditions

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Renal Failure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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naproxcinod

naproxcinod 750mg(375mg caps x2), administered twice a day.

Group Type EXPERIMENTAL

naproxcinod

Intervention Type DRUG

750mg

Interventions

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naproxcinod

750mg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male or female aged 18 to 75 years with stable mild to moderate renal insufficiency.
* Male or female aged 18 to 75 years with similar distribution of age, weight, gender, smoking habits, and race, and in general good health

Exclusion Criteria

* Any significant acute or chronic disease (except renal impairment) which may interfere with study evaluations.
* A history of alcohol or drug abuse.
* Diagnosis of gastric or duodenal ulceration and/or history of significant gastro-duodenal bleeding within the last 6 months
* Clinically relevant abnormal ECG
* Current or expected use of anticoagulants or analgesic, anti-inflammatory therapies except low dose aspirin (less than or equal to 325mg per day).
* Participation within 30 days prior to screening in another investigational study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes