Clinical trial NCT01469416: Drug Interaction Study of Clopidogrel and Rosuvastatin
Official title: The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: rosuvastatin
clopidogrel
pharmacokinetics
drug interaction
healthy volunteer
drug transporter
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.


Eligibility criteria: 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

Primary outcomes:
measure: Area-under-the-concentration curve (AUC) of rosuvastatin
timeFrame: Blood samples collected over a 48 hour period
Secondary outcomes:
measure: Maximum plasma concentration (Cmax) of rosuvastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
measure: Time to concentration maximum (Tmax) of rosuvastatin
timeFrame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Clinical Research Center, UCSF
state: California
Study officials:
References: