Healthy Volunteers Clinical Trial
Official title:
Pharmacokinetics, Dialysability and Safety of P03277, a New Gadolinium-based Contrast Agent, in Healthy Volunteers and in Patients With Impaired Renal Function
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.
A full range design including the different degrees of renal impairment and healthy
volunteers used as reference has been chosen.
Enrolment will be successive starting with both healthy volunteers (cohort 1) and patients
with mild renal impairment (cohort 2), then patients with moderate renal impairment (cohort
3), then patients with severe renal impairment (cohort 4) to end with patients with end stage
renal disease (cohort 5). Pharmacokinetics and safety profiles following the confinement
period will be reviewed per each successive cohort by a Data Monitoring Committee before
starting recruitment of patients in the next cohort. Cohorts 1 and 2 will be recruited in
parallel and Data Monitoring Committee review will start after the completion of these first
two cohorts.
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