Study to Determine the Effects of Co-Administration of Alcohol on the Absorption of Oxycodone From a Proprietary Controlled-Release Formulation
An Open-label, Single-dose, Randomized, Three-way Crossover Study to Estimate the Effects of Ethanol 20% and 40% on the Bioavailability a Controlled Release Formulation of Oxycodone 20 Mg With Sequestered Naltrexone 2.4 Mg in Healthy Volunteers
1 other identifier
interventional
19
1 country
1
Brief Summary
The study is designed to test whether or not the rate and extent of absorption of oxycodone from a proprietary controlled-release formulation is significantly affected by co-administration of alcohol compared with controlled conditions (when the formulation is administered with water). The primary pharmacokinetic parameters are the peak concentration of oxycodone (Cmax) and the overall exposure level of oxycodone as represented by the area under the plasma concentration-time curve (AUC).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Sep 2012
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
First Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 11, 2012
December 1, 2012
3 months
August 29, 2012
December 10, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum observed oxycodone concentration in plasma (Cmax)
hours after dosing
Area under the oxycodone concentration versus time curve (AUC)
hours after dosing
Secondary Outcomes (3)
Time-to-peak concentration (Tmax)
hours after dosing
half-life of drug
hours after dosing
Vital signs and adverse events
hours after dosing
Study Arms (3)
Treatment A
ACTIVE COMPARATORTreatment B
EXPERIMENTALTreatment C
EXPERIMENTALInterventions
single dose of 20 mg of test formulation with 240 mL of water
single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
single dose of 20 mg of test formulation with 240 mL of 40% ethanol
Eligibility Criteria
You may qualify if:
- healthy volunteers
- history of moderate alcohol consumption
- total body weight exceeding 64 kg
You may not qualify if:
- history of clinically significant disease
- history of sleep apnea
- any condition affecting drug absorption
- pregnant or nursing female subjects
- history of allergy or hypersensitivity to either oxycodone or naltrexone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Related Publications (1)
Malhotra BK, Matschke K, Wang Q, Bramson C, Salageanu J. Effects of ethanol on the pharmacokinetics of extended-release oxycodone with sequestered naltrexone (ALO-02). Clin Drug Investig. 2015 Apr;35(4):267-74. doi: 10.1007/s40261-015-0278-6.
PMID: 25724154DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
September 1, 2012
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
December 11, 2012
Record last verified: 2012-12