Healthy Volunteers
Conditions
Keywords
Pharmacokinetics Safety Tolerability Pharmacodynamics
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.
Interventions
DRUGPF-05105679
Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy Volunteers
Exclusion criteria
Standard Healthy Volunteers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium
Outcome results
None listed