Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
- Registration Number
- NCT01393652
- Lead Sponsor
- Pfizer
- Brief Summary
This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679. The second part (Part B) of this study will focus on the exploratory pharmacodynamics of PF-05105679 using pharmacodynamics markers (cold detection) in healthy volunteers. The doses selected in Part B will have been administered previously in the Part A of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 32
Inclusion Criteria
Healthy Volunteers
Exclusion Criteria
Standard Healthy Volunteers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Cohort 1: Experimental intervention: PF-05105679 or placebo PF-05105679 Cohort 1 Cohort 2: Experimental intervention: PF-05105679 or placebo PF-05105679 Cohort 2 Cohort 3: Experimental intervention PF-05105679 or placebo and PF-05105679 Cohort 3
- Primary Outcome Measures
Name Time Method Number of participants with adverse events as a measure of safety and tolerability. 3 days Pharmacokinetics of single doses of PF-05105679 as measured by plasma concentrations- Cmax, Tmax, half life, AUC last, AUC(0-24) and MRT 3 days
- Secondary Outcome Measures
Name Time Method Average AUC2min VAS (cold pressor test) of PF-05105679. 24 hours Cold detection threshold (°C) of PF-05105679. 24 hours Cold pain threshold (°C) of PF-05105679. 24 hours Stimulus-response function to cold stimuli following menthol application. 24 hours
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇧🇪Bruxelles, Belgium