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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01456507

Enrollment

Registered

2011-10-20

Start date

2011-10-31

Completion date

2012-01-31

Last updated

2018-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Food effect, bioavailability, oxycodone, sequestered Naltrexone, management of moderate to severe pain

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

Interventions

DRUGALO-02 (Oxycodone Naltrexone)

single dose of ALO-02 capsule under fasting condition

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026