Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: PF-05105679
* Drug: PF-05105679
* Drug: PF-05105679


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Volunteers Exclusion Criteria: Standard Healthy Volunteers

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Experimental intervention: PF-05105679 or placebo<br>Cohort 1 | Drug: PF-05105679<br>* Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679<br>|
| Experimental: Cohort 2: Experimental intervention: PF-05105679 or placebo<br>Cohort 2 | Drug: PF-05105679<br>* Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679<br>|
| Active Comparator: Cohort 3: Experimental intervention PF-05105679 or placebo and<br>Cohort 3 | Drug: PF-05105679<br>* Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics Safety Tolerability Pharmacodynamics