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This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose | Experimental | 3 way crossover with randomized placebo substitution to evaluate single escalating oral doses of PF 04447943 in 9 healthy young adult subjects. |
|
| Multiple dose | Experimental | 3:1 active PF 04447943 to placebo randomization in 8 healthy elderly subjects. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04447943 | Drug | 3 mg solution, oral single dose. |
| |
| PF-04447943 |
| Measure | Description | Time Frame |
|---|---|---|
| AEs (spontaneous and solicited). Change from baseline in vital signs. | Day 0 to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) | |
| ECG and clinical safety laboratory endpoints, including a complete blood count, a full chemistry panel (including electrolytes and hepatic transaminases) and urinalysis. | Screening visit to follow up visit after Study Day 5(single dose arm) and Day 11(multiple dose arm) | |
| Pharmacokinetic (single): AUClast, Cmax, Tmax | Day 1 to day 5 | |
| Pharmacokinetic(multiple): AUCt, Cmax and Tmax on Days 1 and 7, and Ctrough on Days 2, 3, 4 and 7. | Day 1 to day 11 |
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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 | Glendale | California | 91206 | United States |
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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 |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C572323 | 6-(4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl)-1-(tetrahydro-2H-pyran-4-yl)-1,5-dihydro-4H-pyrazolo(3,4-d)pyrimidin-4-one |
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| Drug |
10 mg solution, oral single dose. |
|
| PF-04447943 | Drug | 25 mg solution, oral single dose. |
|
| Placebo | Drug | Solution, oral single dose. |
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| PF-04447943 | Drug | 25 mg solution, oral twice daily for 7 days. |
|
| Placebo | Drug | Solution, oral twice daily for 7 days. |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |