Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Placebo-controlled Four Way Crossover Study to Asses the Effect of a Single Oral Dose of NKTR-118 on QTc Interval in Healthy Male Subjects

NCT01325415

Amount of NKTR-118 in Blood Variation in the Heart's Electrical Cycle

COMPLETED PHASE1

Electrophysiological Effects of Tipranavir Co-administered With Ritonavir on the QT Interval in Healthy Female and Male Subjects

NCT02248883

Healthy

COMPLETED PHASE1

Tolerability and Potential ECG Effects After a Single Oral Dose of Pentoxyverine Citrate in Healthy Male and Female Volunteers

NCT02183649

Healthy

COMPLETED PHASE1

A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities

NCT06107036

Healthy

COMPLETED PHASE1

Effect of BI 1356 as Single Dose on the QT Interval in Healthy Female and Male Subjects

NCT02183467

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lead in Phase

Supratherapeutic dose of cangrelor

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs

A

therapeutic dose cangrelor treatment

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule

B

supratherapeutic dose cangrelor treatment

Group Type EXPERIMENTAL

cangrelor

Intervention Type DRUG

60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule

C

active comparator treatment

Group Type ACTIVE_COMPARATOR

moxifloxacin

Intervention Type DRUG

400 mg orally. Placebo IV bolus and infusion.

D

placebo treatment

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo IV and oral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cangrelor

IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs

Intervention Type DRUG

cangrelor

30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule

Intervention Type DRUG

cangrelor

60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule

Intervention Type DRUG

moxifloxacin

400 mg orally. Placebo IV bolus and infusion.

Intervention Type DRUG

placebo

placebo IV and oral

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or non pregnant female between 18 years and 45 years of age, inclusive.
2. 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.
3. A body mass index (BMI) of 19 kg/m2 to 28 kg/m2, inclusive.
4. Agrees to abstain from alcohol consumption for at least 3 days before first dosing with study drug and throughout study participation.
5. Agrees to abstain from caffeine and nicotine replacement therapy during the days of study drug administration and serial ECG measurements.
6. No clinically significant abnormal findings on the physical examination, ECG, blood pressure, heart rate, medical history, or clinical laboratory tests during screening.
7. Serum magnesium and potassium levels within the normal range per the local lab at the time of screening.
8. Healthy volunteer as determined by the screening assessments.
9. Willing and able to comply with all trial requirements.
10. Provide written informed consent before initiation of any study related procedures.

Exclusion Criteria

1. Known or suspected pregnancy.
2. 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.
3. 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).
4. 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.
5. Resting pulse rate of \<50 beats per minute (bpm) or \>100 bpm.
6. 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).
7. Personal history of long QT syndrome, heart failure, or hypokalemia.
8. Personal history of unexplained syncope.
9. Immediate-family history of long QT syndrome.
10. Family history of sudden death.
11. Concurrent medical conditions, therapy, or medications that affect the ECG, especially prolongation of the QT/QTc interval.
12. 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.
13. 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.
14. Current smokers or subjects who have discontinued smoking fewer than 6 months prior to study entry.
15. 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.
16. Clinically significant abnormalities in clinical laboratory test results.
17. Positive virology screen for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
18. Positive urine test for drugs of abuse or alcohol.
19. Clinically significant disease or condition affecting a major organ system, including, but not limited to, gastrointestinal, renal, hepatic, bronchopulmonary, neurological, metabolic or cardiovascular disease.
20. Allergy, hypersensitivity, or contraindication to quinolone antibiotics, cangrelor, or any of their excipients.
21. History of multiple adverse drug allergies of any origin.
22. 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.
23. 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.
24. Inability to give informed consent or high likelihood of being unable to complete the necessary confinement.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes