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Genotype-Phenotype-Correlation of Drug-Metabolising Enzymes

Phase 1
Conditions
Drug metabolism of healthy participants
Registration Number
DRKS00017626
Lead Sponsor
niversitätsklinikum Schleswig-Holstein (UKSH)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
200
Inclusion Criteria

Age 18-55 years
Laboratory values in normal range: Elektrolytes (Na, K, Cl, Ca), Creatinin, Urea, Albumin, Hemoglobin, Hematokrit, INR <1.5
No severe pathologic findings in the cardiovascular, renal, pulmonal, hematopoetical, hepatic or neuronal system
No acute pathology during screening
Informed consent

Exclusion Criteria

Known hypersensitivity to the probe drug cocktail
Laboratory values outside reference range (as judged by the investigator)
Pregnancy
Contraception with hormonal contraceptives
Drug use within 3 days before phenotyping
Expected non-compliance
Other absolute and relative contraindications of the probe drugs
Other conditions that might render the subject inappropriate for this trial (as judged by the investigator)
Concurrent participation in another clinical trial

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Metabolic ratios of probe drugs and their metabolites (Blood sample 5 hours after application of drug cocktail or during 8 hours after application as urine collection.)
Secondary Outcome Measures
NameTimeMethod
Genome-wide association study of metabolic ratios
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