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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456546

Enrollment

Registered

2011-10-20

Start date

2011-10-31

Completion date

2013-07-31

Last updated

2013-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CYP2C19 Genotypes

Keywords

CYP2C19*17, Pharmacokinetics, Pharmacodynamics

Brief summary

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

Interventions

DRUGProguanil

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

DRUGClopidogrel

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Daily medication * Alcohol abuse * Pregnancy * Breastfeeding

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026