Status:
COMPLETED
Drug Interaction Study of Clopidogrel and Rosuvastatin
Lead Sponsor:
University of California, San Francisco
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine if clopidogrel inhibits hepatic uptake transport of rosuvastatin clinically.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01469416
Start Date
March 1 2012
End Date
May 1 2013
Last Update
July 18 2014
Active Locations (1)
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1
Clinical Research Center, UCSF
San Francisco, California, United States, 94143