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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: ALO-02 (Oxycodone Naltrexone)

• Registration Number: NCT01456507
• Lead Sponsor: Pfizer

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.

Detailed Description

Bioavailability

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-18
• Study First Posted: 2011-10-20
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-26
• Last Update Posted: 2018-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	ALO-02 (Oxycodone Naltrexone)	1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
B	ALO-02 (Oxycodone Naltrexone)	1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
C	ALO-02 (Oxycodone Naltrexone)	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.	over 120 hours
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States