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To determine if PF-04457845 at doses of 0.5mg, 1mg, 4mg, and 8 mg given once daily for 14 days will be safe and well tolerated in healthy volunteers. To determine the effect on food on PF-04457845 pharmacokinetics and safety following administration of single doses of 4mg and 8mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 0.5mg per day for 14 days. |
|
| Cohort 2 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 1mg per day for 14 days. |
|
| Cohort 3 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 4mg per day for 14 days. |
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| Cohort 4 (N=10) | Experimental | Placebo-controlled, escalating multiple doses of 8mg per day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04457845, FAAH inhibitor | Drug | Oral solution of 0.5mg given once daily for 14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the multiple-dose pharmacokinetics of PF-04457845. | 14 Days | |
| To characterize the relationship between PF-04457845 and the level of anandamide and level of FAAH enzyme inhibition in healthy adult volunteers following multiple dosing. | 14 Days | |
| To evaluate the safety and tolerability of multiple oral doses of PF-04457845. | 14 Days | |
| To determine the effect on food on PF-04457845 pharmacokinetics following administration of single doses of 4mg and 8mg. | 7-14 Days | |
| To determine the effect on food on PF-04457845 safety following administration of single doses of 4mg and 8mg. | 7-14 Days |
| Measure | Description | Time Frame |
|---|---|---|
| CogState/GMLT | 14 Days | |
| Telemetry | 14 Days | |
| Neurologic Exam |
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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 | Singapore | 188770 | Singapore |
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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-04457845, FAAH inhibitor |
| Drug |
Oral solution of 1mg given once daily for 14 days. |
|
| PF-04457845, FAAH inhibitor | Drug | Oral solution of 4mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 4mg will be administered once daily for 14 days. |
|
| PF-04457845, FAAH inhibitor | Drug | A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase |
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| PF-04457845, FAAH inhibitor | Drug | Oral solution of 8mg will be administered as a single dose 7-14 days prior to the multiple dosing phase where 8mg will be administered once daily for 14 days. |
|
| PF-04457845, FAAH inhibitor | Drug | A randomized food treatment will be administered 7-14 days prior to and on day 1 of the multiple dosing phase |
|
| 14 Days |
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C560620 | N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide |
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