To study the pharmacokinetics and safety of naproxcinod in patients with impaired renal function
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
750mg
Unnamed facility
Orlando, Florida, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Saint Paul, Minnesota, United States
To assess differences in the plasma pharmacokinetics profile of naproxcinod and naproxen (total and unbound) between renal impaired patients and healthy subjects.
Time frame: 8 days
To assess differences in the plasma and urinary pharmacokinetic profile of naproxcinod metabolites between renal impaired patients and healthy subjects.
Time frame: 8 days
To assess the general safety of naproxcinod in renal impaired patients and in healthy subjects as shown by the biological tolerance and the adverse events (AE) profile.
Time frame: 8 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.