Measure Exposure Of Tanezumab In Healthy Volunteers When... | NCT00788294

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

NCT00788294

Sponsor

Pfizer

Status

Completed

Last Update Posted

Oct 6, 2020Actual

Enrollment

76Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

tanezumab
tanezumab
tanezumab
tanezumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Nov 7, 2008

First Submission Date that Met QC Criteria

Nov 7, 2008

First Posted Date

Nov 10, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2020

Last Update Posted Date

Oct 6, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
10 mg IV	Active Comparator	Biological: tanezumab
5 mg SC	Active Comparator	Biological: tanezumab
10 mg SC	Active Comparator	Biological: tanezumab
19 mg SC	Active Comparator	Biological: tanezumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tanezumab	Biological	Drug solution given intravenously only once at dose of 10 mg	10 mg IV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subcutaneous bioavailability		16 weeks
Injection site reactions		16 weeks
Immunogenicity		16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Nerve growth factor levels		16 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Cypress	California	90630	United States

References Module

Citations

Not provided