NCT01456546

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 20, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

1.8 years

First QC Date

October 6, 2011

Last Update Submit

July 2, 2013

Conditions

CYP2C19 Genotypes

Keywords

CYP2C19*17PharmacokineticsPharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • Proguanil pharmacokinetics. Primary endpoint is cycloguanil formation clearance.

    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 Outcomes (1)

  • 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

Study Arms (2)

Period A: proguanil

ACTIVE COMPARATOR

Proguanil pharmacokinetics

Drug: Proguanil

Period B: clopidogrel

ACTIVE COMPARATOR

Clopidogrel pharmacokinetics

Drug: Clopidogrel

Interventions

ProguanilDRUG

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

Period A: proguanil
ClopidogrelDRUG

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

Period B: clopidogrel

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Daily medication
  • Alcohol abuse
  • Pregnancy
  • Breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Pharmacology, University of Southern Denmark

Odense, Fyn, DK-5000, Denmark

Location

MeSH Terms

Interventions

ProguanilClopidogrel

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 20, 2011

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

DK(1)