Drug Interaction Study of Clopidogrel and Rosuvastatin

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Leslie Benet, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01469416
First received: October 28, 2011
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention
Healthy
Drug: Rosuvastatin
Drug: Clopidogrel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: The Effects of Administering Clopidogrel on the Pharmacokinetics of Rosuvastatin in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Area-under-the-concentration curve (AUC) of rosuvastatin [ Time Frame: Blood samples collected over a 48 hour period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum plasma concentration (Cmax) of rosuvastatin [ Time Frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]
  • Time to concentration maximum (Tmax) of rosuvastatin [ Time Frame: predose, 0, 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 36, and 48 hours post-dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: March 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Rosuvastatin Drug: Rosuvastatin
Rosuvastatin 20 mg PO x 1
Experimental: Rosuvastatin + clopidogrel Drug: Rosuvastatin
Rosuvastatin 20 mg PO x 1
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)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01469416

Locations
United States, California
Clinical Research Center, UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
  More Information

No publications provided

Responsible Party: Leslie Benet, Professor, Bioengineering and Therapeutic Sciences, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01469416     History of Changes
Other Study ID Numbers: 11-07522
Study First Received: October 28, 2011
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
rosuvastatin
clopidogrel
pharmacokinetics
drug interaction
healthy volunteer
drug transporter

Additional relevant MeSH terms:
Clopidogrel
Ticlopidine
Rosuvastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on April 22, 2014