Acute Response Capsaicin Flare Study

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NCT01147432

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Study Location
Pfizer Investigational Site
Bruxelles, , B-1070, Belgium
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Contact
1-800-718-1021
[email protected]
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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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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
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Advanced Information
Descriptive Information
Brief Title  ICMJE Acute Response Capsaicin Flare Study
Official Title  ICMJE A Double Blind, Randomized, Placebo-Controlled, Third-Party Open, Modified Cross-Over Study To Examine The Acute Effect Of PF-04427429 On Capsaicin Flare Response In Healthy Volunteers Using EMLA Cream As Positive Control
Brief Summary 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 Proof of mechanism in healthy volunteers
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-04427429
    Single dose IV infusion up to 300mg
  • Other: 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
  • Drug: Placebo
    Placebo IV infusion (saline) to be administered during two of the three treatment periods
  • Other: EMLA positive control
    2g EMLA cream to be applied ONCE during study period 1
Study Arms  ICMJE
  • Experimental: PF-04427429
    Interventions:
    • Drug: PF-04427429
    • Other: Capsaicin challenge
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Other: Capsaicin challenge
  • Active Comparator: EMLA
    Intervention: Other: EMLA positive control
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: December 19, 2011)		12
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2010)		24
Actual Study Completion Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 50 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 NCT01147432
Other Study ID Numbers  ICMJE B0141006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP