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.
Proof of mechanism in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
12
Single dose IV infusion up to 300mg
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 IV infusion (saline) to be administered during two of the three treatment periods
Pfizer Investigational Site
Brussels, Belgium
Mean blood perfusion induced by capsaicin challenge, between 30 and 60 minutes post each administration of capsaicin
Time frame: 7 weeks post first dose
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
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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
2g EMLA cream to be applied ONCE during study period 1