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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

July 31, 2010

Study Completion Date

July 31, 2010

Conditions
PharmacokineticsMRILiverDrug TransporterGd-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®

Trial Locations (1)

17487

Department of Clinical Pharmacology at the University of Greifswald, Greifswald

All Listed Sponsors
lead

University Medicine Greifswald

OTHER

NCT01420211 - Influence of the OATP1B1 and OATP1B3 Genotype on the Hepatic Uptake of Primovist® | Biotech Hunter | Biotech Hunter