drugset / Trial / NCT01845194
Repeated Dose Study for the Investigation of Heritability of and Genetic Influences on Drug Pharmacokinetics
NaSingle-groupOpen-labelBasic science
Summary
This human pharmacokinetic study investigates, whether processes of drug metabolism and transport are determined by genetic or hereditary factors. Therefore, approved drugs are applied to twins and metabolism and transport processes are investigated.
Timeline
- Start
- 2009-12
- Primary completion
- 2013-10
- Completion
- 2013-10
Publications
- Matthaei J, Bonat WH, Kerb R, Tzvetkov MV, Strube J, Brunke S, Sachse-Seeboth C, Sehrt D, Hofmann U, von Bornemann Hjelmborg J, Schwab M, Brockmoller J. Inherited and Acquired Determinants of Hepatic CYP3A Activity in Humans. Front Genet. 2020 Aug 21;11:944. doi: 10.3389/fgene.2020.00944. eCollection 2020.
- Matthaei J, Tzvetkov MV, Gal V, Sachse-Seeboth C, Sehrt D, Hjelmborg JB, Hofmann U, Schwab M, Kerb R, Brockmoller J. Low heritability in pharmacokinetics of talinolol: a pharmacogenetic twin study on the heritability of the pharmacokinetics of talinolol, a putative probe drug of MDR1 and other membrane transporters. Genome Med. 2016 Nov 8;8(1):119. doi: 10.1186/s13073-016-0372-2.
- Matthaei J, Brockmoller J, Tzvetkov MV, Sehrt D, Sachse-Seeboth C, Hjelmborg JB, Moller S, Halekoh U, Hofmann U, Schwab M, Kerb R. Heritability of metoprolol and torsemide pharmacokinetics. Clin Pharmacol Ther. 2015 Dec;98(6):611-21. doi: 10.1002/cpt.258. Epub 2015 Oct 19.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | 50 mg | Oral |
| Subject | Codeine | Small molecule | 5 mg | Oral |
| Subject | Metoprolol | Other / unclassified | 5 mg | Oral |
| Subject | Midazolam | Small molecule | 0.2 mg | Oral |
| Subject | Midazolam | Small molecule | 1 mg | Oral |
| Subject | Pravastatin | Small molecule | 5 mg | Oral |
| Subject | Talinolol | Small molecule | 2.5 mg | Oral |
| Subject | Talinolol | Small molecule | 50 mg | Oral |
| Subject | Torsemide | Other / unclassified | 0.25 mg | Oral |
| Subject | Torsemide | Other / unclassified | 2.5 mg | Oral |