drugset / Trial / NCT03337945
In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis
NaSingle-groupOpen-labelDiagnostic
Summary
Subjects will receive the "Basel phenotyping cocktail" capsule orally with 120-200ml tap water in fasted state. After intake peripheral venous blood samples will be drawn. 12 patients (male and female) with liver cirrhosis for each Child Pugh Category A, B, and C, and 12 age- and gender-matched healthy control subjects will be included (in total 48 participants).
Timeline
- Start
- 2018-04-04
- Primary completion
- 2021-06-30
- Completion
- 2021-12-31
Publications
- Duthaler U, Bachmann F, Ozbey AC, Umehara K, Parrott N, Fowler S, Krahenbuhl S. The Activity of Members of the UDP-Glucuronosyltransferase Subfamilies UGT1A and UGT2B is Impaired in Patients with Liver Cirrhosis. Clin Pharmacokinet. 2023 Aug;62(8):1141-1155. doi: 10.1007/s40262-023-01261-3. Epub 2023 Jun 16.
- Duthaler U, Bachmann F, Suenderhauf C, Grandinetti T, Pfefferkorn F, Haschke M, Hruz P, Bouitbir J, Krahenbuhl S. Liver Cirrhosis Affects the Pharmacokinetics of the Six Substrates of the Basel Phenotyping Cocktail Differently. Clin Pharmacokinet. 2022 Jul;61(7):1039-1055. doi: 10.1007/s40262-022-01119-0. Epub 2022 May 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caffeine | Small molecule | — | Oral |
| Subject | Efavirenz | Other / unclassified | — | Oral |
| Subject | Flurbiprofen | Small molecule | — | Oral |
| Subject | Metoprolol | Other / unclassified | — | Oral |
| Subject | Midazolam | Small molecule | — | Oral |
| Subject | Omeprazole | Other / unclassified | — | Oral |