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PER977 administration following a single dose of enoxaparin
Single escalating doses of PER977 from 100 to 300 mg, of 25 mg PER977 x 4 doses will be administered following administration of enoxaparin. Serial pharmacokinetic and pharmacodynamic assessments ( whole blood clotting time) will be performed. Adverse events will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 100 mg PER977 (10 subjects); the dose may be repeated two (2) times after an approximate one (1) hour interval for a maximum total of three (3) doses |
|
| Cohort 2 | Experimental | 200 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour for a maximum total of two (2) doses |
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| Cohort 3 | Experimental | 300 mg PER977 (10 subjects); the dose may be repeated once at approximately one hour after the initial dose for a maximum of total of two (2) doses |
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| Cohort 4 | Experimental | 4 x 25 mg PER977 (10 subjects); study drug will be administered every 30 minutes for a total of 4 doses (cumulative dose of 100 mg PER977) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PER977 | Drug | reversal of edoxaban-induced anticoagulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Assessment of the number of subjects who experience adverse events and the number and type of adverse events | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Reversal of enoxaparin anticoagulation | Measurement of the degree of change in whole blood clotting time and the proportion of subjects who achieve complete or partial reversal of anticoagulation | 1 day |
| Pharmacokinetics of enoxaparin |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Rasmussen, MD | Quintiles, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles | Overland Park | Kansas | 66211 | United States |
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| ID | Term |
|---|---|
| C000593571 | PER977 |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
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| Placebo | Drug | Reversal of edoxaban-induced anticoagulation |
|
| enoxaparin | Drug |
|
Measurement of the pharmacokinetic characteristics of enoxaparin
| 1 day |
| Pharmacokinetics of PER977 and its metabolite | Measurement of the pharmacokinetic characteristics of PER977 and its metabolite | 2 days |
| D002241 |
| Carbohydrates |