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Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways. This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.
Proof of mechanism in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04427429 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| EMLA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04427429 | Drug | Single dose IV infusion up to 300mg |
| |
| Capsaicin challenge |
| Measure | Description | Time Frame |
|---|---|---|
| Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin | 7 weeks post first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety | 12 weeks post final dose | |
| Plasma concentrations of free PF-04427429 | 6 weekly following week 15 |
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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 | 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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| Other |
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period |
|
| Placebo | Drug | Placebo IV infusion (saline) to be administered during two of the three treatment periods |
|
| Capsaicin challenge | Other | Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period |
|
| EMLA positive control | Other | 2g EMLA cream to be applied ONCE during study period 1 |
|
| Plasma concentrations of free and total CGRP | 6 weekly following week 15 |
| Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin. | 7 weeks post first dose |