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Normal subjects will receive unfractionated heparin followed by a single dose of PER977 with dose escalation by cohort. Ten subjects enrolled in Cohort 4 will receive a single dose of PER977 followed by a one-week washout and then will receive unfractionated heparin followed by a single dose of PER977. The study will provide some insight into the doses that may be required to reverse anticoagulation induced by heparin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 100 mg PER977 or placebo administered following heparin sodium |
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| Cohort 2 | Experimental | 200 mg PER977 or placebo administered following heparin sodium |
|
| Cohort 3 | Experimental | 300 mg PER977 or placebo administered following heparin sodium |
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| Cohort 4 | Experimental | 400 mg PER977 or placebo administered as a single agent followed by 3-day wash-out. A second dose of 400 mg PER977 or placebo will be administered following heparin sodium injection |
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| Cohort 5 | Experimental | 500 mg PER977 or placebo will be administered following heparin sodium injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PER977 | Drug | Reversal of heparin-induced anticoagulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of PER977 on reversal of heparin anticoagulation | To identify a dose of PER977 that reverses the effects of heparin as measured by whole blood clotting time | Single day dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of PER977 administered following heparin | Number of participants with adverse events following the administration of PER977 | Single day dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Lomeli, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles | Overland Park | Kansas | 66211 | United States |
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| Cohort 6 | Experimental | 600 mg PER977 or placebo will be administered following heparin sodium injection |
|
| Placebo | Drug | Reversal of heparin-induced anticoagulation |
|
| Heparin Sodium | Drug |
|
| ID | Term |
|---|---|
| C000593571 | PER977 |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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