Healthy Volunteers Study to Estimate the Effects of Food on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Formulation of Oxycodone With Sequestered Naltrexone

Study Overview
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Brief Summary
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The purpose of this study is to estimate the effects of food and of sprinkling ALO-02 pellets on applesauce on the bioavailability of oxycodone and naltrexone/6- beta-naltrexol from an extended release pellets-in-capsule formulation of oxycodone 40 mg with sequestered naltrexone 4.8 mg.

Detailed Description
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Bioavailability

Official Title
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An Open-Label, Single-Dose, Randomized, Three-Way Crossover Study in Healthy Volunteers to Estimate the Effects of Food and of Sprinkling ALO-02 Pellets on Applesauce on the Bioavailability of Oxycodone and Naltrexone/6- Β -Naltrexol From a Extended Release Pellets-in-Capsule Formulation of Oxycodone 40 Mg With Sequestered Naltrexone 4.8 Mg

Conditions
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Healthy

Intervention / Treatment
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* Drug: ALO-02 (Oxycodone Naltrexone)
* Drug: ALO-02 (Oxycodone Naltrexone)
* Drug: ALO-02 (Oxycodone Naltrexone)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive Exclusion Criteria: Evidence or history of clinically significant diseases

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: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions. | Drug: ALO-02 (Oxycodone Naltrexone)<br>* single dose of ALO-02 capsule under fasting condition<br>|
| Experimental: B<br>1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast). | Drug: ALO-02 (Oxycodone Naltrexone)<br>* single dose of ALO-02 capsule under fed condition<br>|
| Experimental: C<br>1×40 mg ALO-02 with the ALO-02 pellets sprinkled approximately on one table spoon of applesauce, and administered with 240 mL of water under fasting conditions. | Drug: ALO-02 (Oxycodone Naltrexone)<br>* ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve (AUC) to time infinity (inf) of oxycodone |  | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | 
| Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone |  | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | 
| Maximum Plasma Concentration (Cmax) of oxycodone |  | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit. |  | predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose | 
| AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit |  | predose, 1,2,4,8,12,24,48,120 hours post-dose | 
| Adverse events, vital signs, pulse oximetry, and safety laboratory parameters. |  | over 120 hours | 

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