A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bipolar Depression

Intervention / Treatment
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* Drug: PF-04455242
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female of non-childbearing potential between the ages of 18 and 55 years. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (>110 lbs). Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures. Exclusion Criteria: Evidence or history of clinically significant medical condition or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening). Use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine or blood cotinine at screening. A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion. | Drug: PF-04455242<br>* 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.<br>|
| Placebo Comparator: Placebo<br>2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion. | Drug: Placebo<br>* PIC matching in appearance to PF-04455242 will be used to administer placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay. |  | Daily | 
| Physical exam |  | Screening, End of Trial (EOT), and Follow Up (F/U) | 
| Clinical safety laboratory results |  | Screening, Day 0 (D0), D2, F/U | 
| 12-lead ECGs |  | 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) . |  | 0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert and Drug Effect Questionnaire (DEQ) questionnaires |  | 0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteer, first in human, safety and tolerability