- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00102674
Pharmacokinetics/Pharmacodynamics (PK/PD) of Cangrelor
August 15, 2011 updated by: The Medicines Company
The Pharmacokinetics and Pharmacodynamics of a Cangrelor Bolus Plus Infusion in Healthy Volunteers
The purposes of this study are to:
- Evaluate the tolerability of two cangrelor regimens.
- Compare the PD of cangrelor regimens with oral clopidogrel.
Study Overview
Detailed Description
The purposes of this study are:
- To evaluate the tolerability of two cangrelor regimens of bolus plus infusion (A and B).
- To characterize the pharmacokinetics of Cangrelor (A and B).
- To compare the pharmacodynamics of cangrelor regimens with that of an oral 600 mg dose of clopidogrel (A, B, C and D).
- To determine the effect of prior cangrelor treatment on the pharmacodynamics of clopidogrel (C and D).
- To determine the effect of prior clopidogrel treatment on the pharmacodynamics of cangrelor (Group D).
- To determine the effects of concomitant clopidogrel and cangrelor exposure on the pharmacodynamics of clopidogrel (Group D).
Study Type
Interventional
Enrollment
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Provide written informed consent before initiation of any study related procedures.
- Age 18 - 55 years
- Normal findings on physical examination.
- A normal 12-lead ECG and normal vital signs (blood pressure, heart rate), unless any abnormality was considered clinically irrelevant by the investigator.
- Normal laboratory and hematology values unless the investigator considered an abnormality to be clinically irrelevant.
- Negative test for pregnancy as determined by urinary b-HCG prior to the administration of study drug for all females of child-bearing potential.
- Body Mass Index (BMI) between 20 and 25 kg/m2 based on actual body weight.
Exclusion Criteria:
- A history of or presence of renal, hepatic, neurological, hematological, gastrointestinal, or psychiatric disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Hypersensitivity to clopidogrel or cangrelor (or the excipients therein).
- Symptoms of a clinically significant illness, or surgery or trauma within 3 months prior to screening.
- Donation of blood or plasma totaling more than 500 mL within the 3 months preceeding the study.
- A significant history of alcohol or drug abuse, a positive urine drug screen, tobacco use within the 3 months preceding enrollment, or alcohol ingestion within 48 hours of dosing.
- A history of hepatitis or human immunodeficiency virus (HIV) or exposure thereto.
- Use of any prescribed medications in the 2 weeks prior to dosing, any aspirin or naproxen-containing medication within 2 weeks of dosing, use of acetaminophen within 24 hours or ibuprofen, vitamins or dietary supplements within 48 hours of dosing (oral contraceptives are permitted).
- Personal or family history of coagulation or bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms; history of important bleeding, (i.e. hematemesis, rectal bleeding, melena, severe or recurrent epistaxis, hemoptysis or intracranial hemorrhage), history of head injury or intracerebral disease, or recent or planned spinal or epidural puncture.
- Significant epigastric pain or "indigestion", either chronically or within 4 weeks prior to screening.
- Diagnosed hypertension, or supine blood pressure at or above 150/90 mmHG or less than 100/50 mmHg at screening.
- Participation in any clinical study with an investigational new drug in the 3 months prior to dosing in the study or participation in a study with a new formulation of a marketed drug in the previous 3 months.
- Anemia or thrombocytopenia (values on screening hematology less than the reporting laboratory's lower limit of normal).
- Any other characteristic or condition which, in the opinion of the investigator, makes participation in this study inappropriate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
To evaluate the tolerability of two cangrelor regimens
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Steven Steinhubl, MD, University of Kentucky
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Study Completion
May 1, 2005
Study Registration Dates
First Submitted
January 31, 2005
First Submitted That Met QC Criteria
January 31, 2005
First Posted (Estimate)
February 1, 2005
Study Record Updates
Last Update Posted (Estimate)
August 16, 2011
Last Update Submitted That Met QC Criteria
August 15, 2011
Last Verified
March 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMC-CAN-04-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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