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
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedSeptember 28, 2018
September 1, 2018
3 months
October 13, 2011
September 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
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
Study Arms (3)
A
EXPERIMENTAL1×40 mg ALO-02 capsule administered with 240 mL of water under fasting conditions.
B
EXPERIMENTAL1×40 mg ALO-02 capsule administered with 240 mL of water under fed conditions (standard high fat breakfast).
C
EXPERIMENTAL1×40 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.
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive
You may not qualify if:
- Evidence or history of clinically significant diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 20, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
September 28, 2018
Record last verified: 2018-09