Status:
COMPLETED
In Vivo Determination of Cytochrome P450 Activities in Patients With Liver Cirrhosis
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 femal...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT03337945
Start Date
April 4 2018
End Date
December 31 2021
Last Update
May 23 2022
Active Locations (1)
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1
Ambulantes Studienzentrum, Universitätsspital Basel
Basel, Switzerland, 4031