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Trial record 1 of 1 for:    NCT00788294
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Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

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ClinicalTrials.gov Identifier: NCT00788294
Recruitment Status : Completed
First Posted : November 10, 2008
Last Update Posted : July 15, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 7, 2008
First Posted Date  ICMJE November 10, 2008
Last Update Posted Date July 15, 2009
Study Start Date  ICMJE November 2008
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
  • Subcutaneous bioavailability [ Time Frame: 16 weeks ]
  • Injection site reactions [ Time Frame: 16 weeks ]
  • Immunogenicity [ Time Frame: 16 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2008)
Nerve growth factor levels [ Time Frame: 16 weeks ]
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 Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Official Title  ICMJE Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
Brief Summary The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
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 Healthy Volunteers
Intervention  ICMJE
  • Biological: tanezumab
    Drug solution given intravenously only once at dose of 10 mg
  • Biological: tanezumab
    Drug solution given subcutaneously only once at dose of 5 mg.
  • Biological: tanezumab
    Drug solution given subcutaneously only once at dose of 10 mg.
  • Biological: tanezumab
    Drug solution given subcutaneously only once at dose of 19 mg.
Study Arms  ICMJE
  • Active Comparator: 10 mg IV
    Intervention: Biological: tanezumab
  • Active Comparator: 5 mg SC
    Intervention: Biological: tanezumab
  • Active Comparator: 10 mg SC
    Intervention: Biological: tanezumab
  • Active Comparator: 19 mg SC
    Intervention: Biological: tanezumab
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 14, 2009)
76
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2008)
72
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Generally healthy
  • BMI of 18-30 kg/m2
  • more than 50 kg bodyweight.

Exclusion Criteria:

  • Pregnant
  • exposure to biologic type drugs within the last 3 months
  • history of allergic or anaphylactic reaction to a biologic drug
  • use of tobacco- or nicotine containing products that is more than what is in 5 cigarettes per day
  • excessive alcohol use.
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 NCT00788294
Other Study ID Numbers  ICMJE A4091013
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 July 2009

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