NCT03657784

Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function

Pharmacokinetics, Dialysability and Safety of P03277, a New Gadolinium-based Contrast Agent, in Healthy Volunteers and in Patients With Impaired Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Guerbet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Renal Insufficiency
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	P03277	Single intravenous bolus injection at 0.1 mmol/kg body weight at a rate of 2 mL/second

Timeline

• Start date: 2017-10-13
• Primary completion: 2019-02-01
• Completion: 2019-08-23
• First posted: 2018-09-05
• Last updated: 2019-10-22

Locations

2 sites across 2 countries: Moldova, Romania

Regulatory

• FDA-regulated drug study