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Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants. Evaluate plasma drug levels and effects on cognition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2). |
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| Cohort 2 | Experimental | Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2). |
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| Cohort 3a | Experimental | Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). |
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| Cohort 3b | Experimental | Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1). |
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| Cohort 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04447943 | Drug | Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests | For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days. | |
| Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax) | For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14 | |
| Maximum plasma concentration (Cmax) | 1 hour post dose day 4 | |
| Minimum plasma concentration ((Ctrough) | For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13 | |
| Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses | For cohorts 1-3, day 7; for cohort 4, day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score | For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days. |
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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 | Gainesville | Florida | 32608 | 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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| PF-04447943 |
| Drug |
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days. |
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| PF-04447943 | Drug | Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts. |
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| PF-04447943 | Drug | Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days. Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts. |
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| PF-04447943 | Drug | Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days. Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts. |
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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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