Acute Response Capsaicin Flare Study

• ClinicalTrials.gov Identifier: NCT01147432
• Recruitment Status: Completed
• First Posted: June 22, 2010
• Last Update Posted: December 21, 2011
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: June 16, 2010
• First Posted Date: June 22, 2010
• Last Update Posted Date: December 21, 2011
• Study Start Date: August 2010
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 (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 (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: Acute Response Capsaicin Flare Study
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator)
• Condition: Healthy

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 19, 2011): 12
• Original Estimated Enrollment (submitted: June 17, 2010): 24
• Actual Study Completion Date: October 2011
• Actual Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT01147432
• Other Study ID Numbers: B0141006
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: December 2011