Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare

Healthy Clinical Trial

Official title:

A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Cross-Over Study To Examine The Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01797796
• Other study ID #: B5281005
• Status: Completed
• Phase: Phase 1
• First received: February 21, 2013
• Last updated: August 19, 2013
• Start date: April 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male Caucasian subjects with skin type I-III inclusive (Fitzpatrick Scale), between the ages of 18 and 55 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).

• An informed consent document signed and dated by the subject.

• Subjects must have a distance from base of scaphoid to antecubital fossa equal of greater to 26 cm on their forearms.

• Subjects who demonstrate a capsaicin -mediated neurogenic flare with a value >200 on the arbitrary Laser Doppler output at any of the time points 30, 40, 50 or 60 minutes following administration of capsaicin at Screening.

Exclusion Criteria:

• Evidence or history of clinically significant hematological (ie, abnormalities due to prolonged exposure to altitude), renal), endocrine or dismetabolic, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or pain condition, dermatological or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

• Subjects with scars or tattoos on the forearms, or with evidence of sunburn, or excessively hairy volar forearms.

• History of febrile illness within 5 days prior to dosing.

Study Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PF-06305591
150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.

Other:
• Capsaicin challenge
110 mg capsaicin cream (Axsain®) will be applied topically at each visit.

Drug:
• Placebo
Placebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.

Other:
• Capsaicin challenge
110 mg capsaicin cream (Axsain®) will be applied topically at each visit.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Brussels

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 (calculated as area under the effect curve [AUEC]) between 40 and 60 minutes post administration of capsaicin in the 3 cm x 3 cm area of capsaicin application.		1 day	No
Secondary	Mean blood perfusion (calculated as AUEC), between 40 and 60 minutes post administration of capsaicin in the 12 cm x 5 cm area of laser Doppler scanning.		1 day	No
Secondary	Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.		1 day	No
Secondary	Peak blood flow perfusion following the first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.		1 day	No
Secondary	Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.		1 day	No
Secondary	Peak blood flow perfusion following the second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of laser Doppler scanning.		1 day	No
Secondary	Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.		1 day	No
Secondary	Mean blood perfusion (calculated as AUEC) post first use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.		1 day	No
Secondary	Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 3 cm x 3 cm area of capsaicin application.		1 day	No
Secondary	Mean blood perfusion (calculated as AUEC) post second use of the Peltier device between 0 and 30 minutes following termination of heat application in the 12 cm x 5 cm area of capsaicin application.		1 day	No
Secondary	Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) 30-60 minutes post topical application of capsaicin cream.		1 day	No
Secondary	Pain Intensity Scores as measured by an 11 point Numerical Rating Scale (NRS) immediately following the first and second application of the heat stimulus.		1 day	No
Secondary	Plasma level of PF 06305591.		2 days	No

External Links

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