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The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06305591 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06305591 | Drug | 150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean blood perfusion (calculated as area under the effect curve [AUEC]) between 40 and 60 minutes post administration of capsaicin in the 3 cm x 3 cm area of capsaicin application. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Mean blood perfusion (calculated as AUEC), between 40 and 60 minutes post administration of capsaicin in the 12 cm x 5 cm area of laser Doppler scanning. | 1 day | |
| Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application. |
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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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| Capsaicin challenge | Other | 110 mg capsaicin cream (Axsain®) will be applied topically at each visit. |
|
| Placebo | Drug | Placebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once. |
|
| Capsaicin challenge | Other | 110 mg capsaicin cream (Axsain®) will be applied topically at each visit. |
|
| 1 day |
| Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning. | 1 day |
| Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application. | 1 day |
| Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning. | 1 day |
| Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application. | 1 day |
| Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application. | 1 day |
| Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application. | 1 day |
| Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application. | 1 day |
| Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) 30-60 minutes post topical application of capsaicin cream. | 1 day |
| Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) immediately following the first and second application of the heat stimulus. | 1 day |
| Plasma level of PF 06305591. | 2 days |