Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers
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
1 other identifier
interventional
24
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the pharmacokinetics of Egalet® morphine when administered with alcohol and compare to administration with water.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 pain
Started Dec 2008
Shorter than P25 for phase_1 pain
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 2, 2008
CompletedFirst Posted
Study publicly available on registry
December 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedSeptember 14, 2016
September 1, 2016
2 months
December 2, 2008
September 12, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Single-dose evaluation
Secondary Outcomes (1)
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
Single-dose evaluation
Study Arms (4)
Treatment A
EXPERIMENTALSingle dose administration of Egalet® morphine with alcohol
Treatment B
EXPERIMENTALSingle dose administration of Egalet® morphine with alcohol
Treatment C
EXPERIMENTALSingle dose administration of Egalet® morphine with alcohol
Treatment D
PLACEBO COMPARATORSingle dose administration of Egalet® morphine with water
Interventions
Extended release tablet combined with alcohol or water
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Egalet Ltdlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christine Andersen, M.Sc.
Egalet A/S
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2008
First Posted
December 4, 2008
Study Start
December 1, 2008
Primary Completion
February 1, 2009
Study Completion
February 1, 2009
Last Updated
September 14, 2016
Record last verified: 2016-09