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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
51
Single oral (PO) dose, PF-05297909 25 mg
Single oral (PO) dose, PF-05297909 100 mg
Single oral (PO) dose, PF-05297909 250 mg
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
New Haven, Connecticut, United States
Plasma area under the curve last (AUClast) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma apparent clearance (CL/F) pharmacokinetic parameter
Time frame: 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
Time frame: Day 0 to Day 3
Plasma area under the curve infinity (AUCinf) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma half-life (t1/2) pharmacokinetic parameter
Time frame: Day 1 to Day 3
Plasma apparent volume of distribution (Vz/F) pharmacokinetic parameter
Time frame: Day 1 to Day 3
CSF concentration summary by time point for PF 05297909.
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of Abeta40
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of Abeta42
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of AbetaX
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of sAPPalpha
Time frame: Day 1 to Day 3
Change from baseline in CSF levels of sAPPbeta.
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Single oral (PO) dose, PF-05297909 525 mg
Single oral (PO) dose, 525 mg
Time frame: Day 1 to Day 3