Clinical trial NCT01147432: Acute Response Capsaicin Flare Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy male volunteers
capsaicin challenge
safety
toleration
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed description: Proof of mechanism in healthy volunteers

Eligibility criteria: 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.

Primary outcomes:
measure: Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
timeFrame: 7 weeks post first dose
Secondary outcomes:
measure: Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety
timeFrame: 12 weeks post final dose
measure: Plasma concentrations of free PF-04427429
timeFrame: 6 weekly following week 15
measure: Plasma concentrations of free and total CGRP
timeFrame: 6 weekly following week 15
measure: Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.
timeFrame: 7 weeks post first dose
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: