NCT01147432CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
PF-04427429
Experimental
Intervention: PF-04427429 (Drug)
PF-04427429
Experimental
Intervention: Capsaicin challenge (Other)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Placebo
Placebo Comparator
Intervention: Capsaicin challenge (Other)
EMLA
Active Comparator
Intervention: EMLA positive control (Other)
Outcomes
Primary Outcomes
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Time Frame: 7 weeks post first dose
Secondary Outcomes
- Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety(12 weeks post final dose)
- Plasma concentrations of free PF-04427429(6 weekly following week 15)
- Plasma concentrations of free and total CGRP(6 weekly following week 15)
- Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.(7 weeks post first dose)
Investigators
Study Sites (1)
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