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

NCT ID: NCT01797796

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2013-07-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-06305591

Group Type EXPERIMENTAL

PF-06305591

Intervention Type DRUG

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

Capsaicin challenge

Intervention Type OTHER

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Capsaicin challenge

Intervention Type OTHER

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

Interventions

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PF-06305591

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

Intervention Type DRUG

Capsaicin challenge

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

Intervention Type OTHER

Placebo

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

Intervention Type DRUG

Capsaicin challenge

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Brussels, , Belgium

Site Status

Countries

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Belgium

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B5281005&StudyName=Effect%20Of%20PF-06305591%20On%20Capsaicin%20And%20Capsaicin/Heat-Induced%20Neurogenic%20Flare

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Other Identifiers

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B5281005

Identifier Type: -

Identifier Source: org_study_id