A Study To Characterize The Pharmacokinetics Of Oxycodone In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is an open-label (both the physician and healthy volunteer know which medication will be administered), single-dose, 6- dosing period study to characterize the pharmacokinetics of oxycodone (process by which oxycodone is absorbed, distributed, metabolized, and eliminated by the body). This study will consist of three parts that will take place over approximately 90 days. Part 1 of the study has 4 dosing periods, while Parts 2 and 3 have one dosing period each.

Detailed Description
-----------------
This study will estimate the PK and relative BA of oxycodone following single oral 40-mg doses of 3 modified PF-00345439 Formulations E, F, and G compared with the reference PF-00345439 Formulation A under fed conditions in healthy volunteers in order to aid in selection of a final formulation.

Official Title
-----------------
Open-Label, Single-Dose, Randomized, Crossover Study To Evaluate The Pharmacokinetics Of Oxycodone Following Oral Administration Of PF-00345439 Under Fed Conditions In Healthy Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone
* Drug: Oxycodone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between 18 and 55 years of age (inclusive). Exclusion Criteria: Evidence or history of clinically significant disease. History of obstructive sleep apnea. Positive urine drug test.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation A, single dose<br>|
| Experimental: Treatment B<br>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation E, single dose<br>|
| Experimental: Treatment C<br>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation F, single dose<br>|
| Experimental: Treatment D<br>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation G, single dose<br>|
| Experimental: Treatment E<br>Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 5 mg PF-00345439 Formulation TBD, single dose<br>|
| Experimental: Treatment F<br>Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration). | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation H, single dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Observed Plasma Concentration (Cmax) of Oxycodone in Treatment E |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 
| Area Under the Curve from Time Zero to Extrapolated Infinite Time [AUC(0-inf)] of Oxycodone in Treatment E |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 
| Area Under the Curve from Time Zero to Last Quantifiable Concentration (AUClast) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 
| Plasma Concentration 24 Hours Post-Dose (C24) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, and 24 hours post-dose. | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 
| Plasma Decay Half-Life (t1/2) |  | 0, 0.5, 1, 2, 4, 6, 8, 12, 14, 16, 24, 36, and 48 hours post-dose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetics, bioavailability, oxycodone.