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

Last updated on May 12, 2018

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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Effect Of PF-06305591 On Capsaicin And Capsaicin/Heat-Induced Neurogenic Flare
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
The purpose of this study is to examine the effect of PF-06305591 on capsaicin and capsaicin/heat-induced neurogenic flare.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Healthy
  • 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.
  • Experimental: PF-06305591
    Interventions:
    • Drug: PF-06305591
    • Other: Capsaicin challenge
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Other: Capsaicin challenge
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
July 2013
July 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01797796
B5281005
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 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 thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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