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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NCT00938301

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Depression
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Depression
Intervention  ICMJE
  • Drug: 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.
  • Drug: Placebo
    PIC matching in appearance to PF-04455242 will be used to administer placebo.
Study Arms  ICMJE
  • Active Comparator: Treatment
    2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
    Intervention: Drug: PF-04455242
  • Placebo Comparator: Placebo
    2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2009)		18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00938301
Other Study ID Numbers  ICMJE B1071001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP