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

CYP2C19 Genotypes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01456546
• Other study ID #: AKF-380
• Status: Completed
• Phase: Phase 1
• First received: October 6, 2011
• Last updated: July 2, 2013
• Start date: October 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy volunteers

• Written consent

• Age 18-65

• CYP2C19*1 and or CYP2C19*17 genotype.

Exclusion Criteria:

• Daily medication

• Alcohol abuse

• Pregnancy

• Breastfeeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• CYP2C19 Genotypes

Intervention

Drug:
• Proguanil
2x350 mg Malarone followed by 3 days of blood- and urine sampling
• Clopidogrel
2x300 mg Plavix followed by 7 hours days of blood sampling

Locations

Country	Name	City	State
Denmark	Clinical Pharmacology, University of Southern Denmark	Odense	Fyn

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.	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.	Hours after administration: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 10, 24, 31, 48, 55	No
Secondary	Pharmacokinetics of the derivatised active clopidogrel metabolite.	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.	Hours after administration: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 5, 6, 7	No