Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation

Study Overview
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Brief Summary
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The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).

Official Title
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An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Test formulation administered with water
* Drug: Test formulation administered with 20% ethanol
* Drug: Test formulation administered with 40% ethanol


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: history of clinically significant disease history of sleep apnea any condition affecting drug absorption pregnant or nursing female subjects history of allergy or hypersensitivity to either oxycodone or naltrexone

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 |
| --- | --- |
| Active Comparator: Treatment A<br> | Drug: Test formulation administered with water<br>* single dose of 20 mg of test formulation with 240 mL of water<br>* Other names: ALO-02 20 mg;|
| Experimental: Treatment B<br> | Drug: Test formulation administered with 20% ethanol<br>* single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water<br>* Other names: ALO-02 20 mg;|
| Experimental: Treatment C<br> | Drug: Test formulation administered with 40% ethanol<br>* single dose of 20 mg of test formulation with 240 mL of 40% ethanol<br>* Other names: ALO-02 20 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed oxycodone concentration in plasma (Cmax) |  | hours after dosing | 
| Area under the oxycodone concentration versus time curve (AUC) |  | hours after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-peak concentration (Tmax) |  | hours after dosing | 
| half-life of drug |  | hours after dosing | 
| Vital signs and adverse events |  | hours after dosing | 

 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