Acute Response Capsaicin Flare Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01147432
• Other study ID #: B0141006
• Status: Completed
• Phase: Phase 1
• First received: June 16, 2010
• Last updated: December 19, 2011
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee Erasme Hospital Brussels
• Study type: Interventional

Clinical Trial 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.

Description:

Proof of mechanism in healthy volunteers

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-04427429
Single dose IV infusion up to 300mg

Other:
• Capsaicin challenge
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period

Drug:
• Placebo
Placebo IV infusion (saline) to be administered during two of the three treatment periods

Other:
• Capsaicin challenge
Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
• EMLA positive control
2g EMLA cream to be applied ONCE during study period 1

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin		7 weeks post first dose	No
Secondary	Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety		12 weeks post final dose	Yes
Secondary	Plasma concentrations of free PF-04427429		6 weekly following week 15	No
Secondary	Plasma concentrations of free and total CGRP		6 weekly following week 15	No
Secondary	Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.		7 weeks post first dose	No

External Links

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