Acute Response Capsaicin Flare Study

NCT01147432 | Completed Phase 1

• 1 other identifier: B0141006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Healthy male volunteers; capsaicin challenge; safety; toleration

Outcome Measures

Primary Outcomes (1)

• Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin

  7 weeks post first dose

Secondary Outcomes (4)

• Adverse Events including dose site reactions, blood pressure, pulse rate, ECG, ADA and laboratory safety

  12 weeks post final dose

• Plasma concentrations of free PF-04427429

  6 weekly following week 15

• Plasma concentrations of free and total CGRP

  6 weekly following week 15

• Mean blood perfusion induced by capsaicin challenge, between 40 and 60 minutes post each administration of capsaicin.

  7 weeks post first dose

Study Arms (3)

PF-04427429

EXPERIMENTAL

Drug: PF-04427429; Other: Capsaicin challenge

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Other: Capsaicin challenge

EMLA

ACTIVE COMPARATOR

Other: EMLA positive control

Interventions

PF-04427429 DRUG

Single dose IV infusion up to 300mg

PF-04427429

Capsaicin challenge OTHER

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

PF-04427429

Placebo DRUG

Placebo IV infusion (saline) to be administered during two of the three treatment periods

Placebo

EMLA positive control OTHER

2g EMLA cream to be applied ONCE during study period 1

EMLA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

Brussels, B-1070, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 21, 2011

Record last verified: 2011-12

Locations

BE (1)