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This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Experimental intervention: PF-05105679 or placebo | Experimental | Cohort 1 |
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| Cohort 2: Experimental intervention: PF-05105679 or placebo | Experimental | Cohort 2 |
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| Cohort 3: Experimental intervention PF-05105679 or placebo and | Active Comparator | Cohort 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05105679 | Drug | Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability. | 3 days | |
| Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average AUC2min VAS (cold pressor test) of PF-05105679. | 24 hours | |
| Cold detection threshold (°C) of PF-05105679. | 24 hours | |
| Cold pain threshold (°C) of PF-05105679. |
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Inclusion Criteria:
Healthy Volunteers
Exclusion Criteria:
Standard Healthy Volunteers
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25125580 | Derived | Winchester WJ, Gore K, Glatt S, Petit W, Gardiner JC, Conlon K, Postlethwaite M, Saintot PP, Roberts S, Gosset JR, Matsuura T, Andrews MD, Glossop PA, Palmer MJ, Clear N, Collins S, Beaumont K, Reynolds DS. Inhibition of TRPM8 channels reduces pain in the cold pressor test in humans. J Pharmacol Exp Ther. 2014 Nov;351(2):259-69. doi: 10.1124/jpet.114.216010. Epub 2014 Aug 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PF-05105679 | Drug | Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679 |
|
| PF-05105679 | Drug | Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses. |
|
| 24 hours |
| Stimulus-response function to cold stimuli following menthol application. | 24 hours |