Drug Interaction Study of Clopidogrel and Rosuvastatin

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Rosuvastatin; Drug: Clopidogrel

• Registration Number: NCT01469416
• Lead Sponsor: University of California, San Francisco

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-28
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-10
• Study Start: 2012-03
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-16
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Rosuvastatin + clopidogrel	Clopidogrel	-
Rosuvastatin + clopidogrel	Rosuvastatin	-
Rosuvastatin	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
Area-under-the-concentration curve (AUC) of rosuvastatin	Blood samples collected over a 48 hour period

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Clinical Research Center, UCSF; 🇺🇸 San Francisco, California, United States