A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
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|ClinicalTrials.gov Identifier: NCT00938301|
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : October 16, 2009
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Depression||Drug: PF-04455242 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||April 2009|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938301
|United States, Connecticut|
|Pfizer Investigational Site|
|New Haven, Connecticut, United States, 06511-5473|
|Study Director:||Pfizer CT.gov Call Center||Pfizer|