This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.
This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma) pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of 300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
22
Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
Placebo which will be dosed as oral suspension, single doses to match PF-06648671
California Clinical Trials Medical Group, Inc.
Glendale, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
CSF Aβ40 and Aβ42 concentration at maximum change from baseline
Time frame: 0-36 hours postdose
Number of participants with AEs and SAEs
Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose. Relatedness to PF-06648671 will be assessed by the investigator (Yes/No). Participants with multiple occurrence of an AE within a category will be counted once within the category
Time frame: 0-2 weeks
supine vital sign
Measurement of supine vital signs
Time frame: 0-2 weeks
Electrocardiogram (ECG)
Measurement of standard 12-lead ECG (single)
Time frame: 0-2 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-72 hours postdose
Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)
Time frame: 0-72 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)
Time frame: 0-72 hours postdose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-72 hours postdose
Plasma Decay Half-life (t1/2)
Time frame: 0-72 hours postdose
Apparent Oral Clearance (CL/F)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0-72 hours postdose
Apparent Volume of Distribution (Vz/F))
Time frame: 0-72 hours postdose
Maximum Observed CSF Concentration (CSF Cmax)
Time frame: 0-36 hours postdose
Area Under the Curve from Time Zero to Last Quantifiable Concentration in CSF (CSF AUClast)
Time frame: 0-36 hours postdose
Area Under the Curve From Time Zero to Extrapolated Infinite Time in CSF (CSF AUCinf)
Time frame: 0-36 hours postdose
CSF Decay Half-life (CSF t1/2)
Time frame: 0-36 hours postdose
Plasma Aβ40, Aβ42 and Aβtotal
Plasma Aβ40, Aβ42 and Aβtotal if possible
Time frame: 0-72 hours postdose
CSF Aβ37, Aβ38 and Aβtotal Concentration
Time frame: 0-36 hours postdose
Number of participants with lab test values of potential clinical importance
Pre-defined criteria were established for each lab test to identify potential clinical importance
Time frame: 0-2 weeks