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

NCT03657784 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-10-22

No results posted yet for this study

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.

Conditions

  • Renal Insufficiency
  • Healthy Volunteers

Interventions

DRUG

P03277

Single intravenous bolus injection at 0.1 mmol/kg body weight at a rate of 2 mL/second

Sponsors & Collaborators

  • Guerbet

    lead INDUSTRY

Principal Investigators

  • Penescu Mircea, MD · Arensia Phase I unit "Carol Davila" Nephrology Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-13
Primary Completion
2019-02-01
Completion
2019-08-23
FDA Drug
Yes

Countries

  • Moldova
  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03657784 on ClinicalTrials.gov