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This is a two part study. The purpose of the first part is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following single escalating doses. Secondary objectives will be to investigate the PK of an alternative formulation of PF-05089771 and the effect of food on the PK of PF-05089771. The second part of the study will focus on investigation of the exploratory pharmacodynamics of PF-05089771 using novel biomarkers in healthy volunteers. The doses selected in Part B will have been administered previously in Part A of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 1 |
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| Cohort 2: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 2 |
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| Cohort 3: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 3 |
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| Cohort 4: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 4 |
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| Cohort 5: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 5 |
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| Cohort 6: Experimental intervention: PF-05089771 or placebo | Experimental | Cohort 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability of PF-05089771. | Days 1-3 | |
| Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) | Days 1-3 | |
| Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) | Days 1-3 | |
| AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL) | Days 1-3 | |
| MRT = Mean residence time of PF-05089771 in the body (hr) | Days 1-3 |
| Measure | Description | Time Frame |
|---|---|---|
| Heat Pain Perception Threshold (HPPT). Measured by applying a heat thermode to the thigh for 1 minute at 47oC. HPPT will be measured at 3 separate doses plus placebo in 12 healthy volunteers. | Hours 1-6 post dose. | |
| Long Thermal Stimulation (LTS). Measured by applying a heat thermode to the thigh at 48oC for 5 seconds. will be measured at 3 separate doses plus placebo in 12 healthy volunteers |
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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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| PF-05089771 | Drug | Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated. |
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| PF-05089771 | Drug | Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. In addition the exploratory pharmacodynamics of PF-05089771 will be investigated using novel biomarkers. |
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| PF-05089771 | Drug | Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. |
|
| PF-05089771 | Drug | Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. |
|
| PF-05089771 | Drug | Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. |
|
| Hours 1-6 post dose. |
| Odor threshold (Sniffin' Sticks). Measured with Sniffin Sticks. Will be measured at 3 separate doses plus placebo in 12 healthy volunteers | Hours 1-6 post dose. |
| Urine: Aet (amount excreted in urine), Aet% and CLr for selected doses dependent on the emerging pharmacokinetics of PF-05089771 where t = 24 hours. | Up to 24 hours |
| AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) | Days 1-3 |
| AUC24 = Area under the curve from the time of dosing to 24 hours post dose (ng.hr/mL) | Days 1-3 |
| CI/F = Clearance of PF-05089771 from plasma corrected for systemic compound availability (L/hr) | Days 1-3 |
| t½ = Elimination half life of PF-05089771 (hr) | Days 1-3 |
| C8 hour = concentration of PF-05089771 in the plasma 8 hours post dose (ng/mL) | Days 1-3 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000618268 | PF-05089771 |
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