Healthy
Conditions
Keywords
rosuvastatin, clopidogrel, pharmacokinetics, drug interaction, healthy volunteer, drug transporter
Brief summary
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.
Interventions
DRUGRosuvastatin
Rosuvastatin 20 mg PO x 1
DRUGClopidogrel
Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area-under-the-concentration curve (AUC) of rosuvastatin | Blood samples collected over a 48 hour period |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed