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

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: NicOx
• Treatments: Naproxen; Naproxen-n-butyl nitrate

Criteria

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.