The purpose of this first in human (FIH) study is to investigate the safety, tolerability, pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects the body) of PF-04455242-01 in healthy adult volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Powder-in Capsule (EP-PIC), will be used to administer doses from 0.5 mg up to and including 56 mg of a single rising dose over 3 treatment periods receiving two doses of PF-04455242 and one dose of placebo. A one-week (minimum) washout will separate each treatment period.
PIC matching in appearance to PF-04455242 will be used to administer placebo.
Pfizer Investigational Site
New Haven, Connecticut, United States
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
Time frame: Daily
Physical exam
Time frame: Screening, End of Trial (EOT), and Follow Up (F/U)
Clinical safety laboratory results
Time frame: Screening, Day 0 (D0), D2, F/U
12-lead ECGs
Time frame: Screening, D1, D2, F/U
Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) .
Time frame: 0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose
Likert and Drug Effect Questionnaire (DEQ) questionnaires
Time frame: 0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.