Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
September 12, 2016 updated by: Egalet Ltd
A Randomized, Partially Blind, Four-way Crossover Study to Determine the Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Male and Female Moderate Drinkers
The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.
Study Overview
Detailed Description
Outcome: Pharmacokinetic parameters
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Main Inclusion Criteria:
- Body mass index (BMI) within the range of 20 to 33 kg/m2 and a minimum weight of at least 50 kg.
- Current alcohol users who are classified as moderate drinkers
- Able to abstain from alcohol during the 48 hour period preceding each study visit
- Free from any clinically significant abnormality on the basis of medical history, vital signs, physical examination, 12-Lead ECG, and laboratory evaluation
Main Exclusion Criteria:
- Intolerance towards alcohol
- History of allergy or hypersensitivity to opioids or related drugs or any excipients
- Any history of drug or alcohol dependence
- Clinically significant abnormalities on physical examination, medical history, 12-Lead ECG, vital signs, or laboratory values
- Gastrointestinal disease or constipation or other clinically significant gastrointestinal problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment A
Single dose administration of Egalet® morphine with alcohol
|
Extended release tablet combined with alcohol or water
|
|
Experimental: Treatment B
Single dose administration of Egalet® morphine with alcohol
|
Extended release tablet combined with alcohol or water
|
|
Experimental: Treatment C
Single dose administration of Egalet® morphine with alcohol
|
Extended release tablet combined with alcohol or water
|
|
Placebo Comparator: Treatment D
Single dose administration of Egalet® morphine with water
|
Extended release tablet combined with alcohol or water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate pharmacokinetic effects of the co-administration of alcohol and Egalet® morphine. AUC0-t, AUC0-inf, Cmax, Residual Area, Tmax, T½ el, and Kel.
Time Frame: Single-dose evaluation
|
Single-dose evaluation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To evaluate the safety and tolerability of the co-administration of alcohol and Egalet® morphine. Hematology, biochemistry, urinalysis, ECG, vital signs, physical examination, and adverse events monitoring
Time Frame: Single-dose evaluation
|
Single-dose evaluation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
December 2, 2008
First Submitted That Met QC Criteria
December 3, 2008
First Posted (Estimate)
December 4, 2008
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MP-EG-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.