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Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00788294
First Posted: November 10, 2008
Last Update Posted: July 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  Purpose
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Condition Intervention Phase
Healthy Volunteers Biological: tanezumab Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Subcutaneous bioavailability [ Time Frame: 16 weeks ]
  • Injection site reactions [ Time Frame: 16 weeks ]
  • Immunogenicity [ Time Frame: 16 weeks ]

Secondary Outcome Measures:
  • Nerve growth factor levels [ Time Frame: 16 weeks ]

Enrollment: 76
Study Start Date: November 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 10 mg IV Biological: tanezumab
Drug solution given intravenously only once at dose of 10 mg
Active Comparator: 5 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 5 mg.
Active Comparator: 10 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 10 mg.
Active Comparator: 19 mg SC Biological: tanezumab
Drug solution given subcutaneously only once at dose of 19 mg.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00788294


Locations
United States, California
Pfizer Investigational Site
Cypress, California, United States, 90630
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00788294     History of Changes
Other Study ID Numbers: A4091013
First Submitted: November 7, 2008
First Posted: November 10, 2008
Last Update Posted: July 15, 2009
Last Verified: July 2009

Keywords provided by Pfizer:
Pharmacokinetics tanezumab subcutaneous bioavailability intravenous Japanese subjects