Pharmacokinetics/Pharmacodynamics (PK/PD) of Cangrelor

This study has been completed.
Sponsor:
Information provided by:
The Medicines Company
ClinicalTrials.gov Identifier:
NCT00102674
First received: January 31, 2005
Last updated: August 15, 2011
Last verified: March 2005
  Purpose

The purposes of this study are to:

  • Evaluate the tolerability of two cangrelor regimens.
  • Compare the PD of cangrelor regimens with oral clopidogrel.

Condition Intervention Phase
Healthy
Drug: cangrelor
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Pharmacokinetics and Pharmacodynamics of a Cangrelor Bolus Plus Infusion in Healthy Volunteers

Further study details as provided by The Medicines Company:

Primary Outcome Measures:
  • To evaluate the tolerability of two cangrelor regimens

Estimated Enrollment: 40
Study Start Date: March 2005
Estimated Study Completion Date: May 2005
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).
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00102674

Locations
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
The Medicines Company
Investigators
Principal Investigator: Steven Steinhubl, MD University of Kentucky
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00102674     History of Changes
Other Study ID Numbers: TMC-CAN-04-02
Study First Received: January 31, 2005
Last Updated: August 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by The Medicines Company:
cangrelor
clopidogrel

Additional relevant MeSH terms:
Cangrelor
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists

ClinicalTrials.gov processed this record on October 23, 2014