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

Last updated on December 4, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01797796
Pfizer
Completed
Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare

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Descriptive Information
Brief Title  ICMJE Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
Official Title  ICMJE 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
Brief SummaryThe purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: PF-06305591
    Interventions:
    • Drug: PF-06305591
    • Other: Capsaicin challenge
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Other: Capsaicin challenge
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2013)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion DateJuly 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01797796
Other Study ID Numbers  ICMJE B5281005
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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