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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-001387-36 | EudraCT Number |
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The purpose of this study is to determine what the study drug does to the body, what the body does to the study drug, and if the study drug is safe and well tolerated when given to adult healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-05230907 and Placebo Cohort 1 | Experimental |
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| PF-05230907 and Placebo Cohort 2 | Experimental |
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| PF-05230907 and Placebo Cohort 3 | Experimental |
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| PF-05230907 and Placebo Cohort 4 | Experimental |
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| PF-05230907 and Placebo Cohort 5 | Experimental |
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| PF-05230907 and Placebo Cohort 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05230907 | Biological | 0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose limiting treatment related adverse events | Through Day 43 | |
| Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events | Through Day 43 | |
| Incidence and magnitude of treatment emergent abnormal laboratory findings | Through Day 43 | |
| Change from baseline in vital sign measurements, ECG parameters, and physical examinations | Through Day 43 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Through 4 hour post dose Day 1 | |
| Maximum Observed Plasma Concentration (Cmax) | Through 4 hour post dose Day 1 | |
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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 Clinical Research Unit | Brussels | B-1070 | Belgium |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo for PF-05230907 | Drug | 0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| PF-05230907 | Biological | 0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose |
|
| Placebo for PF-05230907 | Drug | 0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| PF-05230907 | Biological | 1 micrograms per kilogram of PF-05230907, IV bolus, single dose |
|
| Placebo for PF-05230907 | Drug | 1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| PF-05230907 | Biological | 2 micrograms per kilogram of PF-05230907, IV bolus, single dose |
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| Placebo for PF-05230907 | Drug | 2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| PF-05230907 | Biological | 3 micrograms per kilogram of PF-05230907, IV bolus, single dose |
|
| Placebo for PF-05230907 | Drug | 3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| PF-05230907 | Biological | 5 micrograms per kilogram of PF-05230907, IV bolus, single dose |
|
| Placebo for PF-05230907 | Drug | 5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose |
|
| Pharmacodynamic activity as measured by prothrombin time/internationalize normalized ration (PT/INR) |
| Through post dose Day3 |
| Pharmacodynamic activity as measured by activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) | Through post dose Day3 |
| Pharmacodynamic activity as measured by thrombin-antithrombin (TAT) complexes | Through post dose Day 2 |
| Pharmacodynamic activity as measured by prothrombin fragments 1+2 (PF1+2) | Through post dose Day 2 |
| Pharmacodynamic activity as measured by D-dimer | Through post dose Day 7 |
| Pharmacodynamic activity as measured by protein C activity | Through post dose Day 2 |
| Pharmacodynamic activity as measured by Factor V activity | Through post dose Day 3 |
| Incidence of antibody immune response | Through post dose Day 43 |
| Factor X activity | Through post dose Day 43 |
| ID | Term |
|---|---|
| C000717013 | PF-05230907 |
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