This is first in human (FIH), double-blind, sponsor open, placebo-control trial to examine the safety, tolerability, pharmacokinetics and pharmacodynamics following a single ascending doses of PF-06648671 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
18
Experimental Pfizer compound which will be dosed as oral suspension
Placebo which will be given as oral suspension
Pfizer Clinical Research Unit
Brussels, Belgium
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 occurences of an AE within a category will be counted once within the category
Time frame: 0-6 weeks
Supine vital sign measurement
Measurement of blood pressure and pulse rate
Time frame: 0-6 weeks
Electrocardiogram (ECG)
Measurement of standard 12-lead ECG, single or triplicate
Time frame: 0-6 weeks
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: 0-6 weeks
Maximum Observed Plasma Concentration (Cmax)
Time frame: 0-72 hours post dose
Area Under the Curve From Time Zeor to Last Quantifiable Concentration (AUClast)
Time frame: 0-72 hours post dose
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf)
Time frame: 0-72 hours post dose
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: 0-72 hours post dose
Plasma Decay Half-life (t1/2)
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Time frame: 0-72 hours post dose
Apparent Oral Clearance (CL/F)
Time frame: 0-72 hours post dose
Apparent Volume of Distribution (Vz/F)
Time frame: 0-72 hours post dose
Plasma Cmax ratio under fed vs fasted conditions
Time frame: 0-72 hours post dose
Plasma AUClast ratio under fed vs fasted condition
Time frame: 0-72 hours post dose
Plasma AUCinf ratio under fed vs fasted conditions
Time frame: 0-72 hours post dose
Plasma Abeta42 Maximum change from baseline
Time frame: 0-72 hours post dose
Plasma Abeta42, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Time frame: 0-72 hours post dose
Plasma Abeta42, Time to Reach Maximum Observed Effect (Tmax)
Time frame: 0-72 hours post-dose
Plasma Abeta40 Maximum change from baseline
Time frame: 0-72 hours post dose
Plasma Abeta40, Area Under the Effect Curve from Time Zero to Last Quantifiable Concentration (AUEC)
Time frame: 0-72 hours post dose
Plasma Abeta40, Time to Reach Maximum Observed Effect (Tmax)
Time frame: 0-72 hours post-dose