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| ID | Type | Description | Link |
|---|---|---|---|
| B5201001 |
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This is a clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential of GMI-1070 in African-American Adult subjects. This is conducted as part of standard drug development.
Safety
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivipansel/Placebo/Moxifloxacin | Experimental | Rivipansel 4.8 gA IV infusion over 20 minutes Phosphate Buffered Saline (PBS) IV infusion over 20 minutes Moxifloxacin (Avelox) 400 mg single oral dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivipansel | Drug | Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV. |
|
| Measure | Description | Time Frame |
|---|---|---|
| QTc, during rivipansel treatment period | QTc, using Fridericia's correction method (QTcF) at each time point during rivipansel treatment period. | prior to dose, through 72 hours after dosing |
| QTc, during placebo treatment period | QTc, using Fridericia's correction method (QTcF) at each time point during placebo treatment period. | prior to dose, through 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| QTc, during moxifloxacin treatment period | QTcF, or any other appropriate correction method at each postdose time point of moxifloxacin treatment. | prior to dose, through 72 hours after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | San Antonio | Texas | 78209 | United States |
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| ID | Term |
|---|---|
| C553182 | rivipansel |
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