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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
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 9, 2009
First Posted Date  ICMJE July 13, 2009
Last Update Posted Date October 16, 2009
Study Start Date  ICMJE April 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2009)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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