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Acute Response Capsaicin Flare Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01147432
First received: June 16, 2010
Last updated: December 19, 2011
Last verified: December 2011
  Purpose
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.

Condition Intervention Phase
Healthy Drug: PF-04427429 Other: Capsaicin challenge Drug: Placebo Other: EMLA positive control Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin [ Time Frame: 7 weeks post first dose ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04427429 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
Placebo Comparator: Placebo Drug: Placebo
Placebo IV infusion (saline) to be administered during two of the three treatment periods
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
Active Comparator: EMLA Other: EMLA positive control
2g EMLA cream to be applied ONCE during study period 1

Detailed Description:
Proof of mechanism in healthy volunteers
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147432

Locations
Belgium
Pfizer Investigational Site
Bruxelles, Belgium, B-1070
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01147432     History of Changes
Other Study ID Numbers: B0141006
Study First Received: June 16, 2010
Last Updated: December 19, 2011

Keywords provided by Pfizer:
Healthy male volunteers
capsaicin challenge
safety
toleration

Additional relevant MeSH terms:
Capsaicin
EMLA
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Anesthetics, Combined

ClinicalTrials.gov processed this record on June 23, 2017