Drug Interaction Study of Clopidogrel and Rosuvastatin

NCT01469416 | Completed Phase 1

• 1 other identifier: 11-07522
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

rosuvastatin; clopidogrel; pharmacokinetics; drug interaction; healthy volunteer; drug transporter

Outcome Measures

Primary Outcomes (1)

• Area-under-the-concentration curve (AUC) of rosuvastatin

  Blood samples collected over a 48 hour period

Secondary Outcomes (2)

• 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

Study Arms (2)

Rosuvastatin

ACTIVE COMPARATOR

Drug: Rosuvastatin

Rosuvastatin + clopidogrel

EXPERIMENTAL

Drug: Rosuvastatin; Drug: Clopidogrel

Interventions

Rosuvastatin DRUG

Rosuvastatin 20 mg PO x 1

Rosuvastatin; Rosuvastatin + clopidogrel

Clopidogrel DRUG

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

Rosuvastatin + clopidogrel

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Clinical Research Center, UCSF

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Rosuvastatin Calcium; Clopidogrel

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Thiophenes; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2011
• First Posted: November 10, 2011
• Study Start: March 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 18, 2014

Record last verified: 2014-07

Locations

US (1)