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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rasmus Steen Pedersen, University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT01456546
First received: October 6, 2011
Last updated: July 2, 2013
Last verified: July 2013
  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:


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.



Enrollment: 31
Study Start Date: October 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01456546

Locations
Denmark
Clinical Pharmacology, University of Southern Denmark
Odense, Fyn, Denmark, DK-5000
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: July 2, 2013
Health Authority: Denmark: Danish Medicines Agency

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

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

ClinicalTrials.gov processed this record on November 20, 2014