A Phase I, Randomized, Placebo-Controlled, Dose Escalating Cross Over Study To Evaluate The Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of PF-05105679 Under Fasted Conditions In Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- PF-05105679
- Conditions
- Healthy Volunteers
- Sponsor
- Pfizer
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy Volunteers
Exclusion Criteria
- •Standard Healthy Volunteers
Arms & Interventions
Cohort 1: Experimental intervention: PF-05105679 or placebo
Cohort 1
Intervention: PF-05105679
Cohort 2: Experimental intervention: PF-05105679 or placebo
Cohort 2
Intervention: PF-05105679
Cohort 3: Experimental intervention PF-05105679 or placebo and
Cohort 3
Intervention: PF-05105679
Outcomes
Primary Outcomes
Number of participants with adverse events as a measure of safety and tolerability.
Time Frame: 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
Time Frame: 3 days
Secondary Outcomes
- 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)