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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003797-13 | EudraCT Number |
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The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetics of PF-06473871 in normal healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 80 mg PF-06473871 | Drug | 80 mg of PF-06473871 or placebo |
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| 160 mg PF-06473871 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| ECGs | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| Blood pressure | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| pulse rate | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| Injection siter reaction | The number and percentage of subjects that experienced injection site reactions will be analyzed. | 6 weeks |
| number of subjects with adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| severity of adverse events | will be reviewed and summarized on an ongoing basis during the study to evaluate the safety of subjects | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 6 weeks | |
| Area under the Concentration-Time Curve (AUC) | AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. |
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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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| Drug |
160 mg of PF-06473871 or placebo |
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| 320 mg PF-06473871 | Drug | 320 mg of PF-06473871 or placebo |
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| 480 mg PF-06473871 | Drug | 480 mg of PF-06473871 or placebo |
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| 6 weeks |
| Maximum Observed Plasma Concentration (Cmax) | 6 weeks |