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

NCT ID: NCT00788294

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-06-30

Brief Summary

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The hypothesis of this study is that subcutaneous administration of tanezumab results in lower drug exposure compared to intravenous administration of tanezumab.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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10 mg IV

Group Type ACTIVE_COMPARATOR

tanezumab

Intervention Type BIOLOGICAL

Drug solution given intravenously only once at dose of 10 mg

5 mg SC

Group Type ACTIVE_COMPARATOR

tanezumab

Intervention Type BIOLOGICAL

Drug solution given subcutaneously only once at dose of 5 mg.

10 mg SC

Group Type ACTIVE_COMPARATOR

tanezumab

Intervention Type BIOLOGICAL

Drug solution given subcutaneously only once at dose of 10 mg.

19 mg SC

Group Type ACTIVE_COMPARATOR

tanezumab

Intervention Type BIOLOGICAL

Drug solution given subcutaneously only once at dose of 19 mg.

Interventions

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tanezumab

Drug solution given intravenously only once at dose of 10 mg

Intervention Type BIOLOGICAL

tanezumab

Drug solution given subcutaneously only once at dose of 5 mg.

Intervention Type BIOLOGICAL

tanezumab

Drug solution given subcutaneously only once at dose of 10 mg.

Intervention Type BIOLOGICAL

tanezumab

Drug solution given subcutaneously only once at dose of 19 mg.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Cypress, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A4091013

Identifier Type: -

Identifier Source: org_study_id

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