A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function (HCT3012-X-106)

NicOx

Status and phase

Completed

Phase 1

Conditions

Renal Failure

Treatments

Drug: naproxcinod

Study type

Interventional

Funder types

Industry

Identifiers

NCT00674856

HCT 3012-X-106

Details and patient eligibility

About

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

Full description

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.