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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00788294
First received: November 7, 2008
Last updated: July 14, 2009
Last verified: July 2009
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Injection site reactions [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • Immunogenicity [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Nerve growth factor levels [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00788294     History of Changes
Other Study ID Numbers: A4091013
Study First Received: November 7, 2008
Last Updated: July 14, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014