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

NCT01797796 | Completed Phase 1

• 1 other identifier: B5281005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

PF-06305591

EXPERIMENTAL

Drug: PF-06305591; Other: Capsaicin challenge

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Other: Capsaicin challenge

Interventions

PF-06305591 DRUG

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

PF-06305591

Capsaicin challenge OTHER

110 mg capsaicin cream (Axsain®) will be applied topically at each visit.

PF-06305591

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2013
• First Posted: February 25, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 20, 2013

Record last verified: 2013-08

Locations

BE (1)