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

This study is currently recruiting participants.
Verified October 2012 by University of Southern Denmark
Sponsor:
Information provided by (Responsible Party):
Rasmus Steen Pedersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01456546
First received: October 6, 2011
Last updated: October 23, 2012
Last verified: October 2012
History of Changes

October 6, 2011
October 23, 2012
October 2011
December 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01456546 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]

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.
Same as current
Not Provided
Not Provided
 
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
CYP2C19 Genotypes
  • Drug: Proguanil
    2x350 mg Malarone followed by 3 days of blood- and urine sampling
  • Drug: Clopidogrel
    2x300 mg Plavix followed by 7 hours days of blood sampling
  • Active Comparator: Period A: proguanil
    Proguanil pharmacokinetics
    Intervention: Drug: Proguanil
  • Active Comparator: Period B: clopidogrel
    Clopidogrel pharmacokinetics
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
33
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding
Both
18 Years to 65 Years
Yes
Contact: Rasmus S Pedersen, MSc PhD +45 65 50 33 05 rpedersen@health.sdu.dk
Denmark
 
NCT01456546
AKF-380
Yes
Rasmus Steen Pedersen, University of Southern Denmark
University of Southern Denmark
Not Provided
Not Provided
University of Southern Denmark
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP