Back to resultsStudy To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
Primary Purpose
Osteoarthritis Pain, Chronic Low Back Pain, Pain Due to Interstitial Cystitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
placebo
tanezumab
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis Pain focused on measuring intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects only
- Female subjects can not be pregnant or be nursing.
- Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
- Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
- Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
- Can not have any problematic skin condition.
- Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo
tanezumab
Arm Description
formulation without active drug
Outcomes
Primary Outcome Measures
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
Secondary Outcome Measures
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01030640
Brief Title
Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
Official Title
A Phase 1, Randomized, Double- Blind (Sponsor-Open), Placebo-Controlled Study To Examine The Density Of Intraepidermal Nerve Fibers After A Single Subcutaneous Administration Of Tanezumab In Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis Pain, Chronic Low Back Pain, Pain Due to Interstitial Cystitis
Keywords
intraepidermal nerve fiber density, IENF, tanezumab, subcutaneous, healthy volunteers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
formulation without active drug
Arm Title
tanezumab
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
single dose of the drug formulation
Intervention Type
Biological
Intervention Name(s)
tanezumab
Intervention Description
single dose of the active drug tanezumab at a dose level of 20 mg
Primary Outcome Measure Information:
Title
To assess the change in intraepidermal nerve fiber (IENF) density in skin biopsies from proximal thigh and distal leg between baseline and postdose time points after a single SC injection of tanezumab 20 mg SC or placebo in healthy volunteers.
Time Frame
16 weeks
Title
To compare the treatment effect between tanezumab 20 mg SC and placebo on the change in IENF density between baseline and postdose time points in skin biopsies from the proximal thigh and distal leg in healthy volunteers.
Time Frame
16 weeks
Title
To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
To evaluate the pharmacokinetics of a single dose of tanezumab 20 mg SC administered in the proximal thigh in healthy volunteers
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects only
Female subjects can not be pregnant or be nursing.
Females and males need to use two types of birth control methods during the length of the study and one of the two methods needs to be a barrier method.
Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria:
Subject can not have any chronic or acute medical condition or have had any chronic illness in the past
Can not have any problematic skin condition.
Females can not have more than 7 alcoholic drinks per week and males can not have more than 14 alcoholic drinks per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A4091046&StudyName=Study%20To%20Assess%20Changes%20In%20The%20Number%20Of%20Nerves%20In%20The%20Skin%20At%20The%20Site%20Where%20Where%20Tanezumab%20Is%20Injected
Description
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Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected
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