Effects of Ethanol on Oxycodone Pharmacokinetics in Healthy Volunteers

Study Overview
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Brief Summary
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To Estimate Bioavailability Of 40 Mg Doses Of Pf-00345439 Formulation K Under Fasting Conditions with 40% Ethanol Compared with Water in Healthy Volunteers

Official Title
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An Open Label, Single Dose, Randomized, Two Way Crossover Study to Estimate Oxycodone Relative Bioavailability in Healthy Volunteers Following Administration of PF 00345439 Formulation K 40 Mg Under Fasting Conditions With 40% Ethanol Compared With Water

Conditions
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Healthy

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers History of moderate alcohol consumption Total body weight exceeding 64 kg Exclusion Criteria: Evidence or history of clinically significant disease. Positive urine drug test History of alcoholism or heavy alcohol consumption

Ages Eligible for Study
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Minimum Age: 21 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> | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions<br>Drug: Naltrexone<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).<br>|
| Experimental: Treatment B<br> | Drug: Oxycodone<br>* One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions<br>Drug: Naltrexone<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).<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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Bioavailability, oxycodone, ethanol interaction, healthy volunteers