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Completed

NCT Number: NCT01456507

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

About this study

Bioavailability

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALO-02 (Oxycodone Naltrexone)

Drug

single dose of ALO-02 capsule under fasting condition

Primary outcomes

  1. Area Under the Curve (AUC) to time infinity (inf) of oxycodone

    Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

  2. Area Under the Curve (AUC) to last quantifiable concentration (last) of oxycodone

    Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

  3. Maximum Plasma Concentration (Cmax) of oxycodone

    Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

Secondary outcomes

  1. C24, Tmax (time at maximum concentration) and half-life of oxycodone, as data permit.

    Time frame: predose, 0.5,1,2,4,6,8,12,14,16,24,36,48 hours post-dose

  2. AUClast, AUCinf, and Cmax of naltrexone and 6-beta-naltrexol, as data permit

    Time frame: predose, 1,2,4,8,12,24,48,120 hours post-dose

  3. Adverse events, vital signs, pulse oximetry, and safety laboratory parameters.

    Time frame: over 120 hours

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 20, 2011
Registry last updated
Sep 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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