HealthyPhase 1NCT00102674
Pharmacokinetics/Pharmacodynamics (PK/PD) of Cangrelor
A Phase 1 study testing cangrelor in people with Healthy, run by The Medicines Company at 1 site in United States.
Trial summary
The purposes of this study are to: Evaluate the tolerability of two cangrelor regimens. Compare the PD of cangrelor regimens with oral clopidogrel. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cangrelor
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to May 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- cangrelor
- Keywords
- cangrelor, clopidogrel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cangrelorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the tolerability of two cangrelor regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2005 (estimated)
- Study startMar 2005
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Steven Steinhubl, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00102674
- Sponsor's protocol ID
- TMC-CAN-04-02
- Status last verified
- Mar 2005
- First submitted
- 31 Jan 2005
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics and Pharmacodynamics of a Cangrelor Bolus Plus Infusion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00102674
- Acronym / sponsor ID
- TMC-CAN-04-02
- Conditions
- Healthy
- Keywords
- cangrelor, clopidogrel
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Study completion
- May 2005
- First posted
- 1 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are to:
- Evaluate the tolerability of two cangrelor regimens.
- Compare the PD of cangrelor regimens with oral clopidogrel.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cangrelor | Drug | – |
Primary outcome
To evaluate the tolerability of two cangrelor regimens
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Steinhubl, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cangrelor in people with Healthy, run by The Medicines Company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the tolerability of two cangrelor regimens. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011; AzTrials last refreshed its copy on 7 Nov 2026.