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The purpose of the study is primarily to determine the safety and toleration and pharmacokinetics of PF-05089771 following escalating multiple doses lasting for 14 days. Dosing will either be administered twice or three times daily. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily 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. |
|
| Cohort 2 PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily 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. |
|
| Cohort 3 PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily 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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| Cohort 4 PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo either twice or thrice daily 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability of PF-05089771 | Days 1-16 | |
| Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL) | Days 1-16 | |
| Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) | Days 1-16 | |
| AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) | Days 1-16 | |
| Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose | Days 14-16 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) | Days 14-16 |
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Inclusion Criteria:
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
An informed consent document signed and dated by the subject
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
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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| 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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| PF-05089771 |
| Drug |
PF-05089771 will be dosed as a suspension twice daily |
|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension either twice or thrice daily |
|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension either twice or thrice daily |
|