Acute Response Capsaicin Flare Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-04427429; Drug: Placebo; Other: EMLA positive control; Other: Capsaicin challenge

• Registration Number: NCT01147432
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2010-06-16
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2010-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-19
• Last Update Posted: 2011-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PF-04427429	PF-04427429	-
PF-04427429	Capsaicin challenge	-
Placebo	Placebo	-
Placebo	Capsaicin challenge	-
EMLA	EMLA positive control	-

Primary Outcome Measures

Name	Time	Method
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin	7 weeks post first dose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇧🇪 Bruxelles, Belgium