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

Phase 1

Completed

• Conditions: CYP2C19 Genotypes
• Interventions: Drug: Proguanil; Drug: Clopidogrel

• Registration Number: NCT01456546
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Status Verified: 2013-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Period A: proguanil	Proguanil	Proguanil pharmacokinetics
Period B: clopidogrel	Clopidogrel	Clopidogrel pharmacokinetics

Primary Outcome Measures

Name	Time	Method
Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.	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 Outcome Measures

Name	Time	Method
Pharmacokinetics of the derivatised active clopidogrel metabolite.	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.

Trial Locations

Locations (1)

Clinical Pharmacology, University of Southern Denmark; 🇩🇰 Odense, Fyn, Denmark