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Influence of the OATP1B1 and OATP1B3 Genotype on the Hepatic Uptake of Primovist®

NCT01420211 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2011-08-19

No results posted yet for this study

Summary

The objective of the study is to assess the hepatic uptake of Primovist® after intravenous administration of 25 µmol/kg body weight in 56 healthy volunteers and in 60 patients with a liver disease in dependence on the OATP1B1- and OATP1B3-genotype.

Conditions

  • Pharmacokinetics
  • MRI
  • Liver
  • Drug Transporter
  • Gd-EOB-DTPA

Interventions

DRUG

Primovist® 0,25 mmol/ml solution for injection

intravenous bolus injection of 25 µmol/kg (=0,1 ml/kg) body weight Primovist® and blood sampling before (serum blank) and 6, 11, 21, 31, 45, 65, 95, 125 min and 3, 4, 6, 8, 12, 24 and 48 h after drug administration

DEVICE

MRI

lmaging of 20 slices (thickness: 3 mm; max. time of imaging 10 s) before and 0.25, 1, 2, 3, 4, 5, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90 and 120 min after intravenous bolus injection of 25 µmol/kg (=0,1 ml/kg) body weight Primovist®

Sponsors & Collaborators

  • University Medicine Greifswald

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Germany

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 NCT01420211 on ClinicalTrials.gov