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Completed

NCT Number: NCT01456546

Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

The aim of this study is to investigate if the genetic variant CYP2C19*17 affects the pharmacokinetics of proguanil and clopidogrel.

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Key information

Conditions

CYP2C19 Genotypes

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology, University of Southern Denmark

Odense, Fyn, DK-5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers
  • Written consent
  • Age 18-65
  • CYP2C19*1 and or CYP2C19*17 genotype.

Exclusion criteria

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding

Treatment and study plan

Proguanil

Drug

2x350 mg Malarone followed by 3 days of blood- and urine sampling

clopidogrel

Drug

2x300 mg Plavix followed by 7 hours days of blood sampling

Primary outcomes

  1. Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.

    Time frame: Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55

    Based on blood- and urine-concentrations of proguanil and the metabolites cycloguanil and 4-chlorphenylbiguanid a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made.

Secondary outcomes

  1. Pharmacokinetics of the derivatised active clopidogrel metabolite.

    Time frame: Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7

    Based on blood-concentrations of the derivatised active metabolite of clopidogrel a comparison of the pharmacokinetic parameters (AUC, Cmax, Tmax, T1/2) between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made.

    Secondly, a comparison of the platelet inhibitory of clopidogrel between the three groups of genotypes (CYP2C19*1/*1, CYP2C19*1/*17 and CYP2C19*17/*17) will be made using the VerifyNow® P2Y12 Test.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Oct 20, 2011
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.