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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| "Basel phenotyping cocktail" capsule | Experimental | Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| "Basel phenotyping cocktail" capsule | Drug | Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration-time profile in plasma | Concentration-time Profiles assessed in Plasma over several time points measuring parent compounds and corresponding metabolites to calculate metabolic ratios | -5 minutes, 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan Krähenbühl | Universitätsspital Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulantes Studienzentrum, Universitätsspital Basel | Basel | 4031 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37328712 | Derived | 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. | |
| 35570253 | Derived |
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Results of Trial will be published in a peer reviewed Journal
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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A single center, single dose, open label, single period study to characterize cytochrome P450 (CYP) isoforms by the use of the Basel Phenotyping cocktail in patients at different stages of liver cirrhosis
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| 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |