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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PF-04427429 administered intravenously to healthy adult volunteers.
Phase 1 clinical trial
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single IV Dose 1 | Experimental |
| |
| Single IV Dose 2 | Experimental |
| |
| Single IV Dose 3 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04427429 | Drug | Single 0.2mg dose of intravenous infusion |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety (incidence/severity of adverse events and clinical laboratory abnormalities, mean change from baseline/placebo in vital signs/body temperature, mean change from baseline in 12 lead electrocardiogram parameters compared to baseline/ placebo) | anticipated time is up to 84 days post dose | |
| Safety continued (categorical summary of QTcF compared to baseline between dose groups and placebo, concentration QTcF relationship, ADA responses, IV injection site reactions) | anticipated time is up to 84 days post dose to 84 days | |
| Pharmacokinetics (Free plasma concentrations of PF-04427429 will be measured by a validated assay and non-compartmental PK parameters will be determined for each dose) | anticipated time is up to 84 days post dose days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (free and total CGRP plasma concentrations will be measured, the PK-PD relationship between plasma PF-04427429 concentrations and free/total CGRP concentrations will be characterized) | anticipated time is up to 84 days |
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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 | Phoenix | Arizona | 85013 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-04427429 |
| Drug |
Single 1mg dose of intravenous infusion |
|
| PF-04427429 | Drug | Single 3 mg dose of intravenous infusion |
|