Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers

Study Overview
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Brief Summary
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To estimate the effect of food on the pharmacokinetics and relative bioavailability of oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K taken whole or after chewing in healthy volunteers. We have described below the two cohorts each with two arms in this crossover study by listing them as four Arms/Groups in order to capture the differences between the cohorts prior to the crossover and after the crossover. 14 participants are planned for the first cohort and 18 participants are planned for the second cohort.

Official Title
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An Open-Label, Randomized, 2-Cohort, Single-Dose, Crossover Study To Estimate The Effects Of Food On Oxycodone Pharmacokinetics Following Oral Administration Of 40 Mg Doses Of Pf 00345439 Formulation K Taken Whole Or After Chewing In Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Oxycodone
* 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 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 K, taken whole, 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, taken whole, single dose, under fed 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, Chewed, single dose, under fasting conditions<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 K, Chewed, 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 | 
| Maximum Observed Plasma Concentration (Cmax) |  | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 | 

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 | 
| Concentration at time 24 hours (C24) |  | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 | 
| Time to Reach Maximum Observed Plasma Concentration (Tmax) |  | 0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, relative bioavailability, food effects, oxycodone