A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
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 Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 1, Placebo-Controlled, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects|
- Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay. [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
- Physical exam [ Time Frame: Screening, End of Trial (EOT), and Follow Up (F/U) ] [ Designated as safety issue: Yes ]
- Clinical safety laboratory results [ Time Frame: Screening, Day 0 (D0), D2, F/U ] [ Designated as safety issue: Yes ]
- 12-lead ECGs [ Time Frame: Screening, D1, D2, F/U ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2009|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Treatment
2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
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.
Placebo Comparator: Placebo
2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
PIC matching in appearance to PF-04455242 will be used to administer placebo.