Acute Response Capsaicin Flare Study
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: PF-04427429 (Drug); Capsaicin challenge (Other); Placebo (Drug); Capsaicin challenge (Other); EMLA positive control (Other)
Phase: Phase 1
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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.
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 design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety
Plasma concentrations of free PF-04427429
Plasma concentrations of free and total CGRP
Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.
Proof of mechanism in healthy volunteers
Minimum age: 18 Years.
Maximum age: 50 Years.
- 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
- 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.
Locations and Contacts
Pfizer Investigational Site, Bruxelles B-1070, Belgium
To obtain contact information for a study center near you, click here.
Starting date: August 2010
Last updated: December 19, 2011