Drug Interaction Study of Clopidogrel and Rosuvastatin
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, San Francisco
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
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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 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 May 23, 2013