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This study is designed to observe the safety and concentrations of PF-05297909 and proteins in both blood and cerebrospinal fluid after a single dose of PF-05297909 in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | Ascending doses in healthy volunteers |
|
| Part 2: CSF PKPD | Experimental | Pharmacokinetic and pharmacodynamic cerebrospinal fluid assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05297909 25 mg | Drug | Single oral (PO) dose, PF-05297909 25 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma area under the curve last (AUClast) pharmacokinetic parameter | Day 1 to Day 3 | |
| Plasma apparent clearance (CL/F) pharmacokinetic parameter | Day 0 to Day 3 | |
| Clinical potency of PF 05297909 for reduction in CSF levels of Abeta40, Abeta42, and/or AbetaX via estimation of the IC50 from a population PK/PD (PPK/PD) model | Day 0 to Day 3 | |
| Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter | Day 1 to Day 3 | |
| Plasma half-life (t1/2) pharmacokinetic parameter | Day 1 to Day 3 | |
| Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter | Day 1 to Day 3 | |
| CSF concentration summary by time point for PF 05297909. | Day 1 to Day 3 | |
| Change from baseline in CSF levels of Abeta40 | Day 1 to Day 3 | |
| Change from baseline in CSF levels of Abeta42 | Day 1 to Day 3 | |
| Change from baseline in CSF levels of AbetaX | Day 1 to Day 3 | |
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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 | ||
| Pfizer Investigational Site |
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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-05297909 100 mg |
| Drug |
Single oral (PO) dose, PF-05297909 100 mg |
|
| PF-05297909 250 mg | Drug | Single oral (PO) dose, PF-05297909 250 mg |
|
| PF-05297909 525 mg | Drug | Single oral (PO) dose, PF-05297909 525 mg |
|
| PF-05297909 525 mg | Drug | Single oral (PO) dose, 525 mg |
|
| Change from baseline in CSF levels of sAPPalpha |
| Day 1 to Day 3 |
| Change from baseline in CSF levels of sAPPbeta. | Day 1 to Day 3 |
| New Haven |
| Connecticut |
| 06511 |
| United States |