HealthyPhase 1NCT00699504
Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers
A Phase 1 study testing cangrelor and moxifloxacin in people with Healthy, run by The Medicines Company at 1 site in United States.
Trial summary
To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- cangrelor and moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Nov 2008
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non pregnant female between 18 years and 45 years of age, inclusive.
- Female subjects of childbearing potential (ie, who have not undergone a hysterectomy, have not had a tubal ligation, have not been postmenopausal for at least 12 consecutive months, or whose partner has not undergone a vasectomy) must commit either to abstain continuously from heterosexual sexual contact or to use two methods of birth control, one of which must be a barrier method (eg, hormonal contraception, latex condom, diaphragm, or cervical cap), beginning at screening and throughout study participation.
- A body mass index (BMI) of 19 kg/m2 to 28 kg/m2, inclusive.
- Agrees to abstain from alcohol consumption for at least 3 days before first dosing with study drug and throughout study participation.
- Agrees to abstain from caffeine and nicotine replacement therapy during the days of study drug administration and serial ECG measurements.
- No clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory tests during screening.
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- Serum magnesium and potassium levels within the normal range per the local lab at the time of screening.
- Healthy volunteer as determined by the screening assessments.
- Willing and able to comply with all trial requirements.
- Provide written informed consent before initiation of any study related procedures.
Who cannot join
- Known or suspected pregnancy.
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery; active bleeding.
- Impaired hemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL).
- Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg or <60 mmHg at screening or baseline. Blood pressure may be retested twice in the supine position at intervals of 5 minutes. Blood pressure is considered sustained if either the systolic or the diastolic pressure exceeds the stated limits after three assessments.
- Resting pulse rate of <50 beats per minute (bpm) or >100 bpm.
- Abnormality in the 12 lead ECG that, in the opinion of the investigator, increases the risk of participating in the study, such as a corrected QT interval (QTcB or QTcF) >450 milliseconds. The following conduction abnormalities may confound QTc analysis and should be avoided: PR >220 milliseconds, second or third degree atrioventricular (AV) block, intraventricular conduction defect (IVCD) with QRS >120 milliseconds, complete left bundle branch block (LBBB), left anterior fascicular block (LAFB), left posterior fascicular block (LPFB), right bundle branch block (RBBB), or Wolff Parkinson White syndrome (WPW) (WPW defined as PR >120 milliseconds, P axis from 1 to 90, QRS complex >120 milliseconds, delta wave present).
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- Personal history of long QT syndrome, heart failure, or hypokalemia.
- Personal history of unexplained syncope.
- Immediate-family history of long QT syndrome.
- Family history of sudden death.
- Concurrent medical conditions, therapy, or medications that affect the ECG, especially prolongation of the QT/QTc interval.
- Use of prescription or over the counter (such as pseudoephedrine containing cold medicines) medication, including herbal remedies and health supplements, known to prolong the QT/QTc interval within 14 days prior to start of the study and throughout study participation.
- Intention to use prescription (other than thyroid hormone replacement if the dose and regimen of such replacement therapy has been stable for at least 4 weeks prior to screening and is expected to remain stable during study participation or hormonal contraception) or over the counter medication, including herbal remedies and health supplements, within 14 days before the initial dose of study drug and throughout study participation. If this situation arises, inclusion of an otherwise suitable volunteer may be at the discretion of the investigator in discussion with the Sponsor.
- Current smokers or subjects who have discontinued smoking fewer than 6 months prior to study entry.
- Donation of any blood or plasma in the last month, or donation of >400 mL of blood within the 3 months preceding study drug administration.
- Clinically significant abnormalities in clinical laboratory test results.
- Positive virology screen for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- Positive urine test for drugs of abuse or alcohol.
- Clinically significant disease or condition affecting a major organ system, including, but not limited to, gastrointestinal, renal, hepatic, bronchopulmonary, neurological, metabolic or cardiovascular disease.
- Allergy, hypersensitivity, or contraindication to quinolone antibiotics, cangrelor, or any of their excipients.
- History of multiple adverse drug allergies of any origin.
- Deemed by the investigator, for any reason, to be inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator.
- Treatment with other investigational agents or devices within the 30 days preceding randomization, planned use of other investigational drugs or devices during study participation, or previous enrollment in this trial.
- Inability to give informed consent or high likelihood of being unable to complete the necessary confinement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Charles River Clinical Services NW
Tacoma, Washington, 98418
About this study
Official title: A Double Blind, Placebo Controlled, Positive Controlled, Randomized, Crossover Study to Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers
To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses.
- Conditions
- Healthy
- Being tested
- cangrelor, moxifloxacin, placebo
- Keywords
- ECG, QT, Effect of study drug on healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cangrelorDrug
IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs
cangrelorDrug
30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule
cangrelorDrug
60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule
moxifloxacinDrug
400 mg orally. Placebo IV bolus and infusion.
placeboDrug
placebo IV and oral
| Study group | Role | What they receive |
|---|---|---|
| Lead in Phase | Experimental | Supratherapeutic dose of cangrelor Receives: Drug: cangrelor |
| A | Experimental | therapeutic dose cangrelor treatment Receives: Drug: cangrelor |
| B | Experimental | supratherapeutic dose cangrelor treatment Receives: Drug: cangrelor |
| C | Active comparator | active comparator treatment Receives: Drug: moxifloxacin |
| D | Placebo comparator | placebo treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in placebo adjusted QTc with the individual correction method (QTcI) following cangrelor administration.
Measured: Baseline to treatment
Secondary outcomes (1)
Plasma concentrations of study drug and metabolite
Measured: Baseline to treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Medicines Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699504
- Sponsor's protocol ID
- TMC CAN 08 01
- Status last verified
- Jan 2012
- First submitted
- 13 Jun 2008
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Green CL, Whellan DJ, Lambe L, Bellibas SE, Wijngaard P, Prats J, Krucoff MW. Electrocardiographic safety of cangrelor, a new intravenous antiplatelet agent: a randomized, double-blind, placebo- and moxifloxacin-controlled thorough QT study. J Cardiovasc Pharmacol. 2013 Nov;62(5):466-78. doi: 10.1097/FJC.0b013e3182a2630d.
PubMed 23921301
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Positive Controlled, Randomized, Crossover Study to Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00699504
- Acronym / sponsor ID
- TMC CAN 08 01
- Conditions
- Healthy
- Keywords
- ECG, QT, Effect of study drug on healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- The Medicines CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 18 Jun 2008 (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.
To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Lead in Phase | Experimental | Drug: cangrelorSupratherapeutic dose of cangrelor |
| A | Experimental | Drug: cangrelortherapeutic dose cangrelor treatment |
| B | Experimental | Drug: cangrelorsupratherapeutic dose cangrelor treatment |
| C | Active comparator | Drug: moxifloxacinactive comparator treatment |
| D | Placebo comparator | Drug: placeboplacebo treatment |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Male or non pregnant female between 18 years and 45 years of age, inclusive.
- Female subjects of childbearing potential (ie, who have not undergone a hysterectomy, have not had a tubal ligation, have not been postmenopausal for at least 12 consecutive months, or whose partner has not undergone a vasectomy) must commit either to abstain continuously from heterosexual sexual contact or to use two methods of birth control, one of which must be a barrier method (eg, hormonal contraception, latex condom, diaphragm, or cervical cap), beginning at screening and throughout study participation.
- A body mass index (BMI) of 19 kg/m2 to 28 kg/m2, inclusive.
- Agrees to abstain from alcohol consumption for at least 3 days before first dosing with study drug and throughout study participation.
- Agrees to abstain from caffeine and nicotine replacement therapy during the days of study drug administration and serial ECG measurements.
Key exclusion criteria (24 listed)
- Known or suspected pregnancy.
- Increased bleeding risk: ischemic stroke within the last year or any previous hemorrhagic stroke, tumor, or intracranial aneurysm; recent (<1 month) trauma or major surgery; active bleeding.
- Impaired hemostasis: known International Normalized Ratio (INR) >1.5; past or present bleeding disorder (including congenital bleeding disorders such as von Willebrand's disease or hemophilia, acquired bleeding disorders, and unexplained clinically significant bleeding disorders), thrombocytopenia (platelet count <100,000/µL).
- Sustained supine systolic blood pressure >140 mmHg or <100 mmHg or a diastolic blood pressure >95 mmHg or <60 mmHg at screening or baseline. Blood pressure may be retested twice in the supine position at intervals of 5 minutes. Blood pressure is considered sustained if either the systolic or the diastolic pressure exceeds the stated limits after three assessments.
- Resting pulse rate of <50 beats per minute (bpm) or >100 bpm.
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 |
|---|---|---|
| cangrelorIV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs | Drug | Lead in Phase |
| cangrelor30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule | Drug | A |
| cangrelor60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule | Drug | B |
| moxifloxacin400 mg orally. Placebo IV bolus and infusion. | Drug | C |
| placeboplacebo IV and oral | Drug | D |
Primary outcome
Change from baseline in placebo adjusted QTc with the individual correction method (QTcI) following cangrelor administration.
Time frame: Baseline to treatment
1 secondary outcome
Plasma concentrations of study drug and metabolite
Time frame: Baseline to treatment
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 18 Jan 2012.
- Derived from this study: PubMed 23921301Green CL, Whellan DJ, Lambe L, Bellibas SE, Wijngaard P, Prats J, Krucoff MW. Electrocardiographic safety of cangrelor, a new intravenous antiplatelet agent: a randomized, double-blind, placebo- and moxifloxacin-controlled thorough QT study. J Cardiovasc Pharmacol. 2013 Nov;62(5):466-78. doi: 10.1097/FJC.0b013e3182a2630d.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and moxifloxacin 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 10 inclusion and 24 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 18 Jan 2012. 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. Some participants in this study may receive a placebo. 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?
Change from baseline in placebo adjusted QTc with the individual correction method (QTcI) following cangrelor administration. (time frame: Baseline to treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699504, which also lists 1 linked publication.
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 18 Jan 2012.