Acute Response Capsaicin Flare Study
December 19, 2011 updated by: Pfizer
A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control
Prior to administering PF-04427429 to patients we wish to increase the understanding of functional effects associated with calcitonin gene related peptide (CGRP) pathways.
This study will examine whether it is possible for a single dose of PF-04427429 to acutely attenuate a capsaicin induced flare response.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Proof of mechanism in healthy volunteers
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bruxelles, Belgium, B-1070
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male subjects between the ages of 18 and 50 years inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests.
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.
- Skintype I-III with a distance from base of scaphoid to antecubital fossa >26cm on their forearms.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing).
- Use of biologics including any live vaccines within 3 months prior to screening or prior treatment with an antibody in a previous clinical trial or treatment with an immunoglobulin in the past 6 months.
- 12-lead ECG demonstrating QTcF >450 msec at screening.
- Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessive hairy volar forearms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Placebo Comparator: Placebo
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Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
Placebo IV infusion (saline) to be administered during two of the three treatment periods
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Active Comparator: EMLA
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2g EMLA cream to be applied ONCE during study period 1
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Experimental: PF-04427429
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Single dose IV infusion up to 300mg
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Time Frame: 7 weeks post first dose
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7 weeks post first dose
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety
Time Frame: 12 weeks post final dose
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12 weeks post final dose
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Plasma concentrations of free PF-04427429
Time Frame: 6 weekly following week 15
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6 weekly following week 15
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Plasma concentrations of free and total CGRP
Time Frame: 6 weekly following week 15
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6 weekly following week 15
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Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.
Time Frame: 7 weeks post first dose
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7 weeks post first dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
June 16, 2010
First Submitted That Met QC Criteria
June 17, 2010
First Posted (Estimate)
June 22, 2010
Study Record Updates
Last Update Posted (Estimate)
December 21, 2011
Last Update Submitted That Met QC Criteria
December 19, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0141006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.