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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
  Purpose

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


Condition Intervention Phase
CYP2C19 Genotypes
 Drug: Proguanil
Drug: Clopidogrel
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



Estimated Enrollment: 33
Study Start Date: October 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Period A: proguanil
Proguanil pharmacokinetics
 Drug: Proguanil
2x350 mg Malarone followed by 3 days of blood- and urine sampling
Active Comparator: Period B: clopidogrel
Clopidogrel pharmacokinetics
 Drug: Clopidogrel
2x300 mg Plavix followed by 7 hours days of blood sampling

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01456546

Contacts
Contact: Rasmus S Pedersen, MSc PhD +45 65 50 33 05 rpedersen@health.sdu.dk

Locations
Denmark
Clinical Pharmacology, University of Southern Denmark Recruiting
Odense, Fyn, Denmark, DK-5000
Contact: Rasmus S Pedersen, MSc PhD     +45 65503305     rpedersen@health.sdu.dk    
Sponsors and Collaborators
University of Southern Denmark
  More Information

No publications provided

Responsible Party: Rasmus Steen Pedersen, Assistant Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT01456546     History of Changes
Other Study ID Numbers: AKF-380
Study First Received: October 6, 2011
Last Updated: October 23, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Southern Denmark:
CYP2C19*17
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
Proguanil
Clopidogrel
Ticlopidine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Platelet Aggregation Inhibitors
Hematologic Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013