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Study To Assess Changes In The Number Of Nerves In The Skin At The Site Where Where Tanezumab Is Injected

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01030640
First received: December 9, 2009
Last updated: April 22, 2011
Last verified: April 2011
History of Changes
  Purpose

Subcutaneous administration of tanezumab can result in changes in the number of nerves around the injection site in the thigh.


Condition Intervention Phase
Osteoarthritis Pain
Chronic Low Back Pain
Pain Due to Interstitial Cystitis
 Other: placebo
Biological: tanezumab
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

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. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • To assess the safety, tolerability and immunogenicity of a single dose of tanezumab 20 mg SC in healthy volunteers. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: December 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
formulation without active drug
 Other: placebo
single dose of the drug formulation
Active Comparator: tanezumab Biological: tanezumab
single dose of the active drug tanezumab at a dose level of 20 mg

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030640

Locations
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

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

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01030640     History of Changes
Other Study ID Numbers: A4091046
Study First Received: December 9, 2009
Last Updated: April 22, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
intraepidermal nerve fiber density
IENF
tanezumab
subcutaneous
healthy volunteers

Additional relevant MeSH terms:
Back Pain
Cystitis
Low Back Pain
Osteoarthritis
Cystitis, Interstitial
Pain
Neurologic Manifestations
Nervous System Diseases
 Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on June 18, 2013