The trial will be performed in 32 healthy subjects and in 60 patients with a liver disease subjected to MR imaging MedDRA version: 8.1 Level: LLT Classification code 10028049 Term: MRI
Conditions
Interventions
Trade Name: Primovist®
Pharmaceutical Form: Solution for injection
Other descriptive name: Gd-EOB-DTPA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 181,43-
Sponsors
Department of Clinical Pharmacology, University of Greifswald
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria – healthy volunteers * age: 18 - 45 years * sex: male and female * ethnic origin: white * body weight: ? 19 kg/m² and ? 27 kg/m² * good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which are judged by the clinical investigator not to differ in a clinical relevant way from the normal state * written informed consent Inclusion criteria – patients * age: 18 - 65 years * sex: male and female * ethnic origin: white * any liver disease (e.g. primary liver tumor, metastatic liver disease, liver cirrhosis, steatosis hepatis) which is subjected to MRI diagnostics * written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria – healthy volunteers • weight less than 45 kg • claustrophobia • cardiac pacemakers, metallic implants or metal-containing tatoos • history of allergic reactions • known hypersensitivity to the study medication or to their adjuvants • existing cardiac or hematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics • existing hepatic and renal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics • existing gastrointestinal diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics • acute or chronic diseases which could affect drug metabolism or elimination • history of any serious psychological disorder • drug or alcohol dependence • positive drug or alcohol screening • smokers of 10 or more cigarettes per day • positive anti-HIV-test, HBs-Ag-test or anti-HCV-test • volunteers who are on a diet which could affect the pharmacokinetics of the drug • heavy tea or coffee drinkers (more than 1L per day) • lactation and pregnancy test positive or not performed • volunteers suspected or known not to follow instructions • volunteers who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study • volunteers liable to orthostatic dysregulation, fainting, or blackouts • participation in a clinical trial during the last 3 months prior to the start of the study • less than 14 days after last acute disease • any systemically available medication within 4 weeks prior to the intended first administration unless because of the terminal elimination half-life complete elimination from the body can be assumed for the drug and/or its primary metabolites (except oral contraceptives) • repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin) • intake of grapefruit containing food or beverages within 7 days prior to administration 5.4 Exclusion criteria – patients • weight less than 45 kg • claustrophobia • cardiac pacemakers, metallic implants or metal-containing tatoos • history of allergic reactions • known hypersensitivity to the study medication or to their adjuvants • acute bleedings within the last two weeks, elevated risk of acute bleedings (ulcer, oesophageal varicosis, regular intake of coumarines) or subnormal haemoglobin value • patients who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to as a result of their participation in the study • patients liable to orthostatic dysregulation, fainting, or blackouts • lactation and pregnancy test positive or not performed • repeated use of drugs during the last 4 weeks prior to the intended first administration, which can influence hepatic biotransformation (e.g. barbiturates, cimetidine, phenytoin, rifampicin) • intake of grapefruit containing food or beverages within 7 days prior to administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the hepatic uptake of Primovist® after intravenous administration of 25 µmol/kg body weight in 32 healthy volunteers and in 60 patients with a liver disease in dependence on the OATP1B1-genotype;Secondary Objective: ;Primary end point(s): pharmacokinetic characteristics of Gd-EOB-DTPA; signal intensity of liver, gallbladder and background noise calculation of the signal-to-noise ratio and of the percentage of enhancement of the signal intensities (percentage of average accumulation) after drug injection | — |
Countries
Germany
Outcome results
None listed