NCT00102674

Brief Summary

The purposes of this study are to:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2005

Completed
28 days until next milestone

Study Start

First participant enrolled

March 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
Last Updated

August 16, 2011

Status Verified

March 1, 2005

First QC Date

January 31, 2005

Last Update Submit

August 15, 2011

Conditions

Healthy

Keywords

cangrelorclopidogrel

Outcome Measures

Primary Outcomes (1)

  • To evaluate the tolerability of two cangrelor regimens

Interventions

cangrelorDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

cangrelor

Study Officials

  • Steven Steinhubl, MD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2005

First Posted

February 1, 2005

Study Start

March 1, 2005

Study Completion

May 1, 2005

Last Updated

August 16, 2011

Record last verified: 2005-03

Locations

US(1)