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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01456507

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

7.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: ALO-02 (Oxycodone Naltrexone) Drug: ALO-02 (Oxycodone Naltrexone) Drug: ALO-02 (Oxycodone Naltrexone)	Phase 1

Detailed Description

Bioavailability

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: A

1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.

Drug: ALO-02 (Oxycodone Naltrexone)

single dose of ALO-02 capsule under fasting condition

Experimental: B

1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).

Drug: ALO-02 (Oxycodone Naltrexone)

single dose of ALO-02 capsule under fed condition

Experimental: C

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)

ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.

Outcome Measures

Primary Outcome Measures

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

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]