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To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram (ECG) at therapeutic and supratherapeutic doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lead in Phase | Experimental | Supratherapeutic dose of cangrelor |
|
| A | Experimental | therapeutic dose cangrelor treatment |
|
| B | Experimental | supratherapeutic dose cangrelor treatment |
|
| C | Active Comparator | active comparator treatment |
|
| D | Placebo Comparator | placebo treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cangrelor | Drug | IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in placebo adjusted QTc with the individual correction method (QTcI) following cangrelor administration. | Baseline to treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentrations of study drug and metabolite | Baseline to treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles River Clinical Services NW | Tacoma | Washington | 98418 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23921301 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 23, 2013 | |
| Reset | Jun 14, 2013 | |
| Release | May 14, 2015 |
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| cangrelor |
| Drug |
30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule |
|
| cangrelor | Drug | 60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule |
|
| moxifloxacin | Drug | 400 mg orally. Placebo IV bolus and infusion. |
|
| placebo | Drug | placebo IV and oral |
|
| Reset | Jun 1, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 23, 2013 | Jun 14, 2013 | |||
| May 14, 2015 | Jun 1, 2015 |
| ID | Term |
|---|---|
| C117446 | cangrelor |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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