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

Phase 1 Completed 67 enrolled The Medicines Company

RandomizedCrossoverTriple-blind

Summary

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

Timeline

Start: 2008-06
Primary completion: 2008-11
Completion: 2008-11

Outcome

Met primary endpoint

paper After cangrelor dosing, change in QTcI was <5 ms at all times points and all corresponding upper 2-sided 90% confidence intervals (CIs) were <10 ms. PMID 23921301 ↗

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cangrelor	Small molecule	4 ug/kg	Intravenous
Subject	Cangrelor	Small molecule	8 ug/kg	Intravenous
Comparator	Moxifloxacin	Small molecule	400 mg	Oral

Indications

No indication recorded.