Drug Interaction Study of Clopidogrel and Rosuvastatin

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Rosuvastatin; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01469416

11-07522

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

Rosuvastatin

Active Comparator group

Treatment:

Drug: Rosuvastatin

Rosuvastatin + clopidogrel

Experimental group

Treatment:

Drug: Clopidogrel

Drug: Rosuvastatin