Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function
Status:
Completed
Trial end date:
2019-08-23
Target enrollment:
Participant gender:
Summary
This is an open-label, non-randomized, successive cohorts design, multicenter, single dose
phase I study.
The primary objectives are:
- to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single
intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal
impairment and in healthy volunteers with normal renal function used as reference.
- to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg
body weight) in patients with end stage renal disease requiring hemodialysis.