Status:
COMPLETED
Influence of the OATP1B1 and OATP1B3 Genotype on the Hepatic Uptake of Primovist®
Lead Sponsor:
University Medicine Greifswald
Conditions:
Pharmacokinetics
MRI
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Gadolinium-ethoxybenzyl-diethylenetriamine-pentaacetic acid (Gadoxetate, Gd-EOB-DTPA, Primovist®) is a newly developed paramagnetic hepatobiliary contrast agent for magnetic resonance imaging (MRI) ba...
Eligibility Criteria
Inclusion
- age: 18 - 45 years
- sex: male and female
- ethnic origin: white
- body weight: 19 to 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
Exclusion
- weight less than 45 kg
- claustrophobia
- cardiac pacemakers, metallic implants or metal-containing tatoos
- history of allergic reactions, allergic deseases (e.g. asthma bronchiale)
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01420211
Start Date
October 1 2006
End Date
July 1 2010
Last Update
August 19 2011
Active Locations (1)
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1
Department of Clinical Pharmacology at the University of Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany, 17487