Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects

NCT01012310

Last updated date
Study Location
Pfizer Investigational Site
Bruxelles, , 1070, Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
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 subjects btween the ages of 18-55 years

- Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

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


- Evidence or history of clinically signifcant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease.


- A positive urine drug screen.


- History of regular alcohol consumption exceeding 21 drinks/week within 6 months of
screening


- Use of tobacco or nicotine containing products in excess of the equivalent of 5
cigarettes per day.


- Pregnant or nursing females; females of childbearing potentioal who are unwilling or
unable to use an acceptable method on contraception.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Official Title  ICMJE A Double Blind, 3rd Party Open, Placebo Controlled, Dose Escalating, Parallel Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Brief Summary The purpose of this study is to determine the safety and toleration of single and multiple doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083 and its metabolites, following single and multiple dose administration in healthy male and/or female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in metabolism of other drugs following multiple dosing).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.
  • Drug: PF-04531083 or Placebo
    A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
Study Arms  ICMJE
  • Experimental: Cohort 1
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 2
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 3
    Intervention: Drug: PF-04531083 or Placebo
  • Experimental: Cohort 4
    Intervention: Drug: PF-04531083 or 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: November 12, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects btween the ages of 18-55 years
  • Body Mass Index (BMI) of 15.5 to 30.5 and a total body weight greater than 50kg (110 lbs).

Exclusion Criteria:

  • Evidence or history of clinically signifcant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
  • A positive urine drug screen.
  • History of regular alcohol consumption exceeding 21 drinks/week within 6 months of screening
  • Use of tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes per day.
  • Pregnant or nursing females; females of childbearing potentioal who are unwilling or unable to use an acceptable method on contraception.
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 Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01012310
Other Study ID Numbers  ICMJE B1351002
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 April 2010

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