Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
NicOx
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.
Age
18–75
Sex
ALL
Healthy volunteers
Accepted
You may be eligible 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 be 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.
