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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-07-31

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.

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Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment

2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.

Group Type ACTIVE_COMPARATOR

PF-04455242

Intervention Type DRUG

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

2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

PIC matching in appearance to PF-04455242 will be used to administer placebo.

Interventions

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PF-04455242

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.

Intervention Type DRUG

Placebo

PIC matching in appearance to PF-04455242 will be used to administer placebo.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes