Measure Exposure Of Tanezumab In Healthy Volunteers When Administering The Drug Subcutaneously - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00788294

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Bio-availability Study
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 ]

Estimated Enrollment:	72
Study Start Date:	November 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
10 mg IV: Active Comparator	Biological: tanezumab Drug solution given intravenously only once at dose of 10 mg
5 mg SC: Active Comparator	Biological: tanezumab Drug solution given subcutaneously only once at dose of 5 mg.
10 mg SC: Active Comparator	Biological: tanezumab Drug solution given subcutaneously only once at dose of 10 mg.
19 mg SC: Active Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00788294

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, California
Pfizer Investigational Site	Recruiting
Cypress, California, United States, 90630

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4091013
Study First Received:	November 7, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00788294
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Pharmacokinetics, tanezumab, subcutaneous, bioavailability, intravenous, healthy volunteers, Japanese subjects.

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009