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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-04

Study Completion Date

2021-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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"Basel phenotyping cocktail" capsule

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

Group Type EXPERIMENTAL

"Basel phenotyping cocktail" capsule

Intervention Type DRUG

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

Interventions

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"Basel phenotyping cocktail" capsule

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes