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Sponsored by: |
The Medicines Company |
Information provided by: | The Medicines Company |
ClinicalTrials.gov Identifier: | NCT00699504 |
To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses.
Condition | Intervention | Phase |
Healthy |
Drug: cangrelor Drug: moxifloxacin Drug: placebo |
Phase I |
ChemIDplus related topics: | Moxifloxacin Moxifloxacin hydrochloride Cangrelor |
Study Type: | Interventional |
Study Design: | Other, Randomized, Double Blind (Subject, Caregiver, Investigator), Crossover Assignment, Safety 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 |
Estimated Enrollment: | 66 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
Lead in Phase: Experimental
Supratherapeutic dose of cangrelor
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Drug: cangrelor
IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs
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A: Experimental
therapeutic dose cangrelor treatment
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Drug: cangrelor
30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule
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B: Experimental
supratherapeutic dose cangrelor treatment
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Drug: cangrelor
60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule
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C: Active Comparator
active comparator treatment
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Drug: moxifloxacin
400 mg orally. Placebo IV bolus and infusion.
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D: Placebo Comparator
placebo treatment
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Drug: placebo
placebo IV and oral
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | The Medicines Company ( Simona Skerjanec / VP, Global Product Development ) |
Study ID Numbers: | TMC CAN 08 01 |
First Received: | June 13, 2008 |
Last Updated: | September 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00699504 |
Health Authority: | United States: Food and Drug Administration |
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