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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ALO-02 (Oxycodone Naltrexone); Drug: ALO-02 (Oxycodone Naltrexone); Drug: ALO-02 (Oxycodone Naltrexone)

Detailed Description

Bioavailability

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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; Drug: ALO-02 (Oxycodone Naltrexone); single dose of ALO-02 capsule under fed condition; Drug: ALO-02 (Oxycodone Naltrexone); ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
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 fasting condition; Drug: ALO-02 (Oxycodone Naltrexone); single dose of ALO-02 capsule under fed condition; Drug: ALO-02 (Oxycodone Naltrexone); ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
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); single dose of ALO-02 capsule under fasting condition; Drug: ALO-02 (Oxycodone Naltrexone); single dose of ALO-02 capsule under fed condition; Drug: ALO-02 (Oxycodone Naltrexone); ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 20, 2011

Study Record Updates

• Last Update Posted (Actual): September 28, 2018
• Last Update Submitted That Met QC Criteria: September 26, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Food effect; bioavailability; oxycodone; management of moderate to severe pain; sequestered Naltrexone
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Alcohol Deterrents; Naltrexone; Oxycodone
• Other Study ID Numbers: B4531003