Cocktail Approach for Cytochrome P450 and P-glycoprotein Activity Assessment Using Dried Blood Spot

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

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-01-31

Brief Summary

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Phenotyping is an approach largely used for the evaluation of the activity of cytochromes and transporters in vivo. It consists of the administration of probe substances metabolised by a specific cytochrome or transported by P-glycoprotein (P-gp) for example, followed by the determination of a metabolic ratio or the evaluation of the plasmatic or urinary concentrations of the probe substances. The administration of a cocktail containing several probe substances allows the simultaneous evaluation of the activity of several cytochromes and P-gp in a single test.

The aim of this project is the validation of a phenotyping cocktail of low dose probe drugs for the assessment of cytochrome P450 and P-gp activities by simple capillary blood sampling and dried blood spot (DBS) analysis. The cocktail consists of caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan, midazolam and fexofenadine for the simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9, CAP2C19, CYP2D6, CYP3A4 and P-gp, respectively.

The modulation of the activity of cytochromes or P-gp will be evaluated by the administration of inhibitors (fluvoxamine, voriconazole, quinidine) or inducer (rifampicin) of the metabolic pathways or the P-gp mediated transport.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CYP1A2, 2B6, 2C9, 2C19, 3A4 inhibitors

Oral intake of fluvoxamine (50 mg per day during 2 days) and voriconazole (400 mg) before oral intake of the cocktail probe drugs

Group Type ACTIVE_COMPARATOR

Cocktail probe drugs

Intervention Type DRUG

CYP2D6 and P-gp inhibitor

Oral intake of quinidine (200 mg) before oral intake of the cocktail probe drugs

Group Type ACTIVE_COMPARATOR

Cocktail probe drugs

Intervention Type DRUG

CYPs and P-gp inducer

Oral intake of rifampicin (600 mg per day during 7 days) before oral intake of the cocktail probe drugs

Group Type ACTIVE_COMPARATOR

Cocktail probe drugs

Intervention Type DRUG

Probe cocktail alone

Oral intake of the cocktail probe drugs :

* bupropion 25 mg
* flurbiprofen 25 mg
* omeprazole 5 mg
* dextromethorphan 5 mg
* midazolam 1 mg
* fexofenadine 25mg
* Caffeine (a cup of coffee)

Group Type EXPERIMENTAL

Cocktail probe drugs

Intervention Type DRUG

Interventions

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Cocktail probe drugs

Intervention Type DRUG

Other Intervention Names

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Oral intake of the cocktail probe drugs : bupropion 25 mg flurbiprofen 25 mg omeprazole 5 mg dextromethorphan 5 mg midazolam 1 mg fexofenadine 25mg Caffeine (a cup of coffee)

Eligibility Criteria

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Inclusion Criteria

* Healthy male volunteers aged from 18 to 60 years
* BMI between 18 and 25
* Understanding of French language and able to give a written inform consent.

Exclusion Criteria

* Smoker
* Taking drugs which alter CYPs activity
* Renal or hepatic impairment
* Medical history of porphyria
* Medical history of chronic alcoholism or abuse of psychoactive drugs
* Liver transplantation
* Sensitivity to any of the drugs used
* Wearing contact lenses (risk of coloration with rifampicin)
* ECG showing long QT interval (\>0.46sec)
* Alteration of hepatic tests
* Presenting genetic polymorphism of poor CYP 2B6, 2C9, 2C19, 2D6 metabolisers

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes