Effects of a Single Dose of Egalet® Morphine Combined With a Single Dose of Alcohol in Healthy Moderate Drinkers

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Morphine sulphate

• Registration Number: NCT00802308
• Lead Sponsor: Egalet Ltd

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.

Detailed Description

Outcome: Pharmacokinetic parameters

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-02
• Study First Submitted QC: 2008-12-03
• Study First Posted: 2008-12-04
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment A	Morphine sulphate	Single dose administration of Egalet® morphine with alcohol
Treatment B	Morphine sulphate	Single dose administration of Egalet® morphine with alcohol
Treatment C	Morphine sulphate	Single dose administration of Egalet® morphine with alcohol
Treatment D	Morphine sulphate	Single dose administration of Egalet® morphine with water

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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