Drug Interaction Study of Clopidogrel and Rosuvastatin

NCT ID: NCT01469416

Last Updated: 2014-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2013-05-31

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: NONE

Study Groups

Rosuvastatin

Group Type: ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 20 mg PO x 1

Rosuvastatin + clopidogrel

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 20 mg PO x 1

Clopidogrel

Intervention Type: DRUG

Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)

Interventions

Rosuvastatin

Rosuvastatin 20 mg PO x 1

Intervention Type: DRUG

Clopidogrel

Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Research Center, UCSF

San Francisco, California, United States

Countries

United States

Other Identifiers

11-07522

Identifier Type: -

Identifier Source: org_study_id