Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01147432
Previous Study | Return to List | Next Study

Acute Response Capsaicin Flare Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01147432
Recruitment Status : Completed
First Posted : June 22, 2010
Last Update Posted : December 21, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 16, 2010
First Posted Date  ICMJE June 22, 2010
Last Update Posted Date December 21, 2011
Study Start Date  ICMJE August 2010
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin [ Time Frame: 7 weeks post first dose ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin. [ Time Frame: 1 week post-dose ]
Change History Complete list of historical versions of study NCT01147432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2011)
  • Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety [ Time Frame: 12 weeks post final dose ]
  • Plasma concentrations of free PF-04427429 [ Time Frame: 6 weekly following week 15 ]
  • Plasma concentrations of free and total CGRP [ Time Frame: 6 weekly following week 15 ]
  • Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin. [ Time Frame: 7 weeks post first dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2010)
  • Adverse Events including dose site reactions, blood pressure, pulse rate, ECG and laboratory safety [ Time Frame: 12 weeks post final dose ]
  • Plasma concentrations of free PF-04427429 [ Time Frame: 1 week post final dose ]
  • Plasma concentrations of free and total CGRP [ Time Frame: 1 week post final dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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