Overview

In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis

Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University Hospital, Basel, Switzerland
Criteria
Inclusion Criteria:

- Full mental and legal capacity.

- Signed informed consent prior to any study related procedure.

- Ability to communicate in German, sufficient to comprehend and adhere to study
protocol.

- Normal physical examination, vital signs, laboratory workup, and CombiCaps LC Study
Protocol Version 1.2 09.08.2017 Page 9 of 50 electrocardiogram (ECG) (in the opinion
of investigator).

- Hematology and clinical chemistry results not deviating from the normal range to a
clinically relevant extent at screening (in the opinion of investigator).

- No other conditions or circumstances that might interfere with compliance with study
protocol (in the opinion of investigator).

Exclusion Criteria:

- Known hypersensitivity to probe substances or any excipient of the drug formulation.

- Ongoing or past treatment with another investigational drug within 30 days prior to
screening.

- Concomitant treatment with drugs that inhibit or induce CYP3A4, CYP2D6, CYP2C9,
CYP2C19, CYP2B6 and CYP1A2 function (in the opinion of investigator).

- Actual infection

- Severe heart failure (NYHA IV).

- Actual alcohol or drug abuse

- Positive results from urine drug screen at screening.

- Excessive caffeine consumption, defined as >800 mg per day at screening*.

- Subjects unwilling to stop consumption of alcoholic- and caffeine-containing beverages
on study days until after the last sampling time-point of the study period.

- Intake of food products (immediately before or during study) known to be inducers or
inhibitors of CYP450 (e.g. grapefruit juice)

- Loss of 250 ml or more of blood within 3 months prior to screening.

- Pregnant or lactating women

- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol.

- Legal incapacity or limited legal capacity at screening. *100 mg caffeine is
approximately 1'000 ml Coca Cola®, 2½ espresso cups or 1 cup of strong coffee.