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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Experimental intervention: PF-05089771 or placebo | Experimental | Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetics (PK) of PF-05089771. |
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| Cohort 2: Experimental intervention: 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. |
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| Cohort 3: Experimental intervention: PF-05089771 or placebo | Experimental | Subjects with osteoarthritis of the knee will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. |
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| Cohort 4: Experimental intervention: PF-05089771 or placebo | Experimental | Elderly Subjects will receive multiple doses of PF-05089771 or placebo twice daily to investigate the safety/tolerability and Pharmacokinetic (PK) of PF-05089771. |
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| Cohort 5: Experimental intervention: 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension twice daily (BID) |
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| 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, 4 and 14 | |
| Tmax = Time of maximum concentration of PF-05089771 in plasma (hr) | Days 1, 6 and 14 | |
| AUCtau= Area under the curve from the time of dosing to the next dose (ng.hr/mL) | Days 1, 6 and 14 | |
| Elimination half life (hr) = rate of elimination of PF-05089771 after the final dose | day 14 PK samples collected only for 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL) | Days 14, over 48 hours of PK samples collection | |
| Daily pain score throughout the treatment period using an 11-point Numeric Rating Scale (NRS). | Days 14, every day over 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
for cohort 3: Evidence of relapse or recurrence of clinically significant endocrine, metabolic, pulmonary, hepatic, osteo-mio-artricular, gastrointestinal, cardiovascular, renal, , psychiatric or neurological disease, or neurological disease less than 28 days prior to screening.
Symptomatic OA of the hip ipsilateral to index knee which the patient considers more painful than the knee. History of diseases other than OA that may involve the index knee in the last 12 months prior to screening, including but not limited to: inflammatory joint diseases (i.e rehumatoid arthritis and gout), calcium crystal diseases, bursitis, tendinitis, tumors and cysts, ligament injuries, bone fractures, post-infective pathologies; widespread chronic pain conditions (ie, fibromyalgia) and neuropathic disorders.
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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 (BID) |
|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension twice daily (BID) |
|
| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension twice daily (BID) |
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| PF-05089771 | Drug | PF-05089771 will be dosed as a suspension BID |
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| Daily time to ascend and descend stairs. | Days 14, every day over 24 hours |
| Daily pain following stair climbing and descending | Days 14, every day over 24 hours |
| Daily time for self paced walk | Days 14, every day over 24 hours |
| Daily pain following self paced walk. | Days 14, every day over 24 hours |