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Acute Response Capsaicin Flare Study

NCT ID: NCT01147432

Last Updated: 2011-12-21

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

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Proof of mechanism in healthy volunteers

Conditions

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Healthy

Keywords

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Healthy male volunteers capsaicin challenge safety toleration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF-04427429

Group Type EXPERIMENTAL

PF-04427429

Intervention Type DRUG

Single dose IV infusion up to 300mg

Capsaicin challenge

Intervention Type OTHER

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Capsaicin challenge

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

EMLA positive control

Intervention Type OTHER

2g EMLA cream to be applied ONCE during study period 1

Interventions

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PF-04427429

Single dose IV infusion up to 300mg

Intervention Type DRUG

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

Intervention Type OTHER

Placebo

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

Intervention Type DRUG

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

Intervention Type OTHER

EMLA positive control

2g EMLA cream to be applied ONCE during study period 1

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 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=B0141006&StudyName=Acute%20Response%20Capsaicin%20Flare%20Study%20

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

Other Identifiers

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B0141006

Identifier Type: -

Identifier Source: org_study_id