Acute Response Capsaicin Flare Study

Condition(s) targeted: Healthy

Intervention: PF-04427429 (Drug); Capsaicin challenge (Other); Placebo (Drug); Capsaicin challenge (Other); EMLA positive control (Other)

Phase: Phase 1

Status: Completed

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

Secondary outcome:

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.

Detailed description: Proof of mechanism in healthy volunteers

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

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.

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