- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01456546
Impact of CYP2C19*17 on the Pharmacokinetics of Proguanil and Clopidogrel
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Fyn
-
Odense, Fyn, Denmark, DK-5000
- Clinical Pharmacology, University of Southern Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Period A: proguanil
Proguanil pharmacokinetics
|
2x350 mg Malarone followed by 3 days of blood- and urine sampling
|
ACTIVE_COMPARATOR: Period B: clopidogrel
Clopidogrel pharmacokinetics
|
2x300 mg Plavix followed by 7 hours days of blood sampling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Antimetabolites
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Clopidogrel
- Proguanil
Other Study ID Numbers
- AKF-380
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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