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Trial record 1 of 1 for:    NCT01119235
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A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.

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ClinicalTrials.gov Identifier: NCT01119235
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : August 6, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE April 19, 2010
First Posted Date  ICMJE May 7, 2010
Last Update Posted Date August 6, 2010
Study Start Date  ICMJE May 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
concentration of PF-04531083 in blood just before dosing on the 8th day of the study [ Time Frame: Days 1 and 8 of the study ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01119235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2010)
pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated. [ Time Frame: Days 1, 8 and 14 of the study ]
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 Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.
Official Title  ICMJE A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers
Brief Summary A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE
  • Drug: PF-04531083
    Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days
  • Drug: PF-04531083
    Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1
Study Arms  ICMJE
  • Active Comparator: Cohort 1: PF-04531083
    Intervention: Drug: PF-04531083
  • Active Comparator: Cohort 2: PF-04531083
    Intervention: Drug: PF-04531083
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: May 5, 2010)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2010
Actual Primary Completion Date July 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Young
  • Healthy volunteers

Exclusion Criteria:

  • Elderly volunteers
  • Patients with any existing medical conditions considered likely to impinge on study execution
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 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 NCT01119235
Other Study ID Numbers  ICMJE B1351005
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 August 2010

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