Expired Study
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Omaha, Nebraska 68131


Purpose:

This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.


Study summary:

Clopidogrel is a prodrug which is transformed in vivo to both an inactive metabolite through esterases and an active form through a series of CYP-mediated steps.The CYP isoenzymes that have been identified as being involved with the metabolism of clopidogrel include CYP1A2, CYP2B6, CYP2C9, CYP2C19, and CYP3A4.There have been a number of reports published citing the variability in response to clopidogrel with one of the potential influences on this variability being drug interactions.Grapefruit juice (GFJ) has been extensively studied in the area of interactions with medications due to its inhibition of both CYP3A4 and more recently its inhibition of esterases. With clopidogrel being metabolized by both CYP3A4 and esterases, there is a theoretical interaction between clopidogrel and GFJ. Whether this potential interaction has an impact on clopidogrel's ability to affect platelet inhibition is currently unknown. This study will examine the effect of GFJ on the loading dose (300mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loading dose. The subjects who have been randomized to receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the morning, followed two hours later by a loading dose (300mg) of clopidogrel and will then return to the clinic 6 hours after their loading dose to have their platelet inhibition measured. Subjects will have ~ 5 milliliters (1 teaspoonful) of whole blood drawn from an antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of platelet aggregation. After their first loading dose, a 2 week washout period will follow to allow for their platelet aggregation to return to normal. Following the washout period, the subjects will take their second loading dose of clopidogrel and again return to the clinic for platelet inhibition measurement. The same timing will be followed for the loading dose taken without prior GFJ.


Criteria:

Inclusion Criteria: - Ages 19-40 - Health status confirmed by medical history and physical examination and laboratory analysis Exclusion Criteria: - Pregnancy - Taking routine prescription or over-the-counter prescriptions - Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of study participation - Recently had grapefruit juice or regularly drinks grapefruit juice


NCT ID:

NCT00817999


Primary Contact:

Principal Investigator
Tammy Burns, PharmD
Creighton Cardiac Center


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68131
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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