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Genotype-Phenotype-Correlation of Drug-Metabolising Enzymes

Genotype-Phenotype-Correlation of Drug-Metabolising Enzymes - CYP-GP-COR-1

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
DRKS
Registry ID
DRKS00017626
Enrollment
200
Registered
2019-08-14
Start date
2011-07-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug metabolism of healthy participants

Interventions

Group 1: Phenotyped group (p.o. drug cocktail of 5 drugs (caffeine, losartan, omeprazole, dextromethorphan, midazolam) to assess metabolic activity (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP3A4)).

Sponsors

Universitätsklinikum Schleswig-Holstein (UKSH)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Genome-wide association study of metabolic ratios

Countries

Germany

Contacts

Public ContactRuwen Böhm

Institut für Experimentelle und Klinische Pharmakologie, UKSH, Campus Kiel

ruwen.boehm@pharmakologie.uni-kiel.de0431 500 30414

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026