Food Effect And Relative Bioavailability Study Of Oxycodone in Healthy Volunteers

Study Overview
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Brief Summary
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To estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers

Detailed Description
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This study will estimate the effect of food (standard high-fat breakfast) on the pharmacokineticsand relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF-00345439 Formulation K in healthy volunteers. Additionally, the study will estimate the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of the test PF-00345439 Formulation K compared with the reference PF-00345439 Formulation X under fasted conditions in healthy volunteers and assess the single-dose safety and tolerability of oxycodone in PF-00345439 formulations in healthy volunteers when administered under a naltrexone block.

Official Title
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An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Food on Oxycodone Pharmacokinetics Following Oral 40 Mg Doses of PF-00345439 Formulation K and to Estimate Its Relative Bioavailability of Oxycodone Compared to PF-003454390 Formulation X in the Fasted State in Healthy Volunteers

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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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 Positive urine drug test

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

Sexes Eligible for Study
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All

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: 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 X, single dose, under fasting conditions<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 K, single dose, under fasting conditions<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 K, single dose, under fed conditions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 
| Concentration at time 24 hours (C24) of oxycodone, as data permit. | Concentration at time 24 hours (C24) of oxycodone, as data permit. | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Time to Reach Maximum Observed Plasma Concentration (Tmax) | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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food effect, pharmacokinetics, bioavailability, oxycodone, management of moderate to severe pain