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

Liver Cirrhosis Clinical Trial

— CombiCapsLC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03337945
• Other study ID #: 2017-01329
• Status: Completed
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• "Basel phenotyping cocktail" capsule
Oral intake of "Basel phenotyping cocktail" capsule and pharmacokinetics (PK) sampling

Locations

Country	Name	City	State
Switzerland	Ambulantes Studienzentrum, Universitätsspital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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