Status:
COMPLETED
A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function
Lead Sponsor:
NicOx
Conditions:
Renal Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
Detailed 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 im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00674856
Start Date
May 1 2008
End Date
October 1 2008
Last Update
January 28 2009
Active Locations (3)
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1
Orlando, Florida, United States
2
Minneapolis, Minnesota, United States
3
Saint Paul, Minnesota, United States