Drug Interaction Study of Clopidogrel and Rosuvastatin

Study Overview
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Brief Summary
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The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.

Official Title
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The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy individuals, male or female, age 18-65 years old, with no current medical conditions or active diagnoses as determined by the study doctor based on history, physical exam and laboratory evaluations Subjects that take no other medications 2 weeks prior to the study and during the time course of the study including prescription medications, over-the-counter medications (except acetaminophen), dietary supplements, or drugs of abuse Subjects with a SLCO1B1*1A genotype Subjects able to maintain adequate birth control during the study independent of hormonal contraceptive use Subjects able to abstain from grapefruit, grapefruit juice, orange juice, caffeinated beverages and/or alcoholic beverages from 3 pm the day before the study to completion of that study day. Participants determined to have normal liver and kidney function as measured at baseline BMI between 18.5 - 30 kg/m2 Subjects capable of fasting from food and beverages at least 8 hours prior to medication dosing Be able to read, speak, and understand English Exclusion Criteria: Subjects with active medical problems Subjects on chronic prescription or OTC medications that cannot be stopped 2 weeks prior to and during the study. Subjects incapable of multiple blood draws (HCT <30 mg/dL) Subjects with a history of rhabdomyolysis Subjects with a history of drug-related myalgias Subjects with a history or diagnosis of hemorrhagic tendencies or blood dyscrasias Subjects with a history of GI bleed or peptic ulcer disease Subjects with a recent history of trauma Subjects with a recent history of or upcoming plan of surgery Subjects that smoke tobacco or have ongoing alcohol or illegal drug use Subjects who are pregnant, lactating, or trying to conceive during the study period Subjects allergic to rosuvastatin or clopidogrel or any known component of the medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin<br> | Drug: Rosuvastatin<br>* Rosuvastatin 20 mg PO x 1<br>|
| Experimental: Rosuvastatin + clopidogrel<br> | Drug: Rosuvastatin<br>* Rosuvastatin 20 mg PO x 1<br>Drug: Clopidogrel<br>* Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area-under-the-concentration curve (AUC) of rosuvastatin |  | Blood samples collected over a 48 hour period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) of rosuvastatin |  | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose | 
| Time to concentration maximum (Tmax) of rosuvastatin |  | predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rosuvastatin, clopidogrel, pharmacokinetics, drug interaction, healthy volunteer, drug transporter