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

Completed · Phase 1

Conditions studied: Renal Failure

In brief

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

Key facts

Study ID

NCT00674856

Run by

NicOx

People needed

32

Starts

2008-05-01

Expected to finish

2008-10-01

Last updated by the study team

2009-01-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Study site — Orlando, Florida, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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