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

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NCT00788294

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Cypress, California, 90630 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Generally healthy

- BMI of 18-30 kg/m2

- more than 50 kg bodyweight.

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

- 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.

NCT00788294
Pfizer
Completed
Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously
Pharmacokinetics And Safety Of A Single Dose Subcutaneous Or Intravenous Administration Of Tanezumab In Healthy Volunteers: An Open-Label, Non-Randomized Phase 1 Study
The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Healthy Volunteers
  • 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.
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
June 2009
June 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00788294
A4091013
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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