NCT01366573

GSK1521498 Alcohol Interaction Study

A Randomised, Double-Blind, Single-Dose, Four-Period Cross-Over Study to Determine the Effects of Alcohol on the Pharmacokinetics and Pharmacodynamics of GSK1521498 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The aim of the study is to assess the safety and tolerability of GSK1521498 in combination with alcohol and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

Detailed description

The study is to test a new drug which may be used for treating alcohol addiction. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much alcohol we drink and the pleasure we get from drinking alcohol. We believe that GSK1521498 might be effective in the treatment of alcohol addiction because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from drinking alcohol. As alcohol can effect the way that a drug is metabolised in the body, The investigators need to determine that it is safe to take GSK1521498 in combination with alcohol. and to determine the amount of GSK1521498 and alcohol in your blood after you have been given these together. The study will also determine whether GSK1521498 will have an effect on alcohol liking and consumption.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	GSK1521498	GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
OTHER	Placebo	Placebo

Timeline

• Start date: 2011-05-13
• Primary completion: 2011-09-16
• Completion: 2011-09-16
• First posted: 2011-06-06
• Last updated: 2017-07-21

Locations

1 site across 1 country: United States