SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT01420211

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Influence of the OATP1B1 and OATP1B3 Genotype on the Hepatic Uptake of Primovist® in Healthy Volunteers and in Patients With Liver Disease

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.

NCT01420211 Pharmacokinetics MRI Liver Drug Transporter Gd-EOB-DTPA

2 Interventions

Name: Primovist® 0,25 mmol/ml solution for injection

Description: 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

Type: Drug

Primovist

Name: MRI

Description: 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®

Type: Device

Primovist


Primary Outcomes

Description: AUC0-t is calculated by the trapezoidal formula. AUC0-t is assessed up to the last sampling time above the limit of quantitation and is extrapolated to infinity using standard techniques. Cmax and Tmax will be obtained directly from the measured concentration-time curves. t1/2 will be evaluated from the terminal slope by log-linear regression analysis.

Measure: Pharmacokinetic characteristics

Time: 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

Description: Dynamic enhanced MR examination with 0.1ml/kg/KG (flow:2ml/s) Gd-EOB-DTPA and breath-hold gradient-echo T1-weighted VIBE images (Volumen interpolated breathhold examination) will be acquired on the 1.5T MRI (Siemens Symphony maestro class). Time of imaging can be seen on the time schedule. The SNR and the time to maximum enhancement will be calculated for each organ.

Measure: signal intensity of liver

Time: before and 0.25, 1, 2, 3, 4, 5, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90 and 120 min after drug administration

Secondary Outcomes

Description: Dynamic enhanced MR examination with 0.1ml/kg/KG (flow:2ml/s) Gd-EOB-DTPA and breath-hold gradient-echo T1-weighted VIBE images (Volumen interpolated breathhold examination) will be acquired on the 1.5T MRI (Siemens Symphony maestro class). Time of imaging can be seen on the time schedule. The SNR and the time to maximum enhancement will be calculated for each organ.

Measure: signal intensity of gallbladder

Time: before and 0.25, 1, 2, 3, 4, 5, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90 and 120 min after drug administration

Description: Dynamic enhanced MR examination with 0.1ml/kg/KG (flow:2ml/s) Gd-EOB-DTPA and breath-hold gradient-echo T1-weighted VIBE images (Volumen interpolated breathhold examination) will be acquired on the 1.5T MRI (Siemens Symphony maestro class). Time of imaging can be seen on the time schedule. The SNR and the time to maximum enhancement will be calculated for each organ.

Measure: signal intensity of background noise

Time: before and 0.25, 1, 2, 3, 4, 5, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90 and 120 min after drug administration

Purpose: Basic Science

Allocation: Non-Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 M233I

At least two of them were described to be of functional relevance: 334T>G (Ser112Ala) and 699G>A (met233Ile). --- Ser112Ala --- --- met233Ile ---


2 S112A

At least two of them were described to be of functional relevance: 334T>G (Ser112Ala) and 699G>A (met233Ile). --- Ser112Ala ---



HPO Nodes