EtOH Interaction Study

• Status: Completed
• Trial end date: 2008-12-03
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the possible effects of alcohol in combination with GSK598809 on the central nervous system in 20 healthy male and female volunteers, between 18 and 65 years of age.

During 4 separate study periods subjects will receive the following treatment combinations:

Alcohol + GSK598809, alcohol + placebo drug, placebo infusion + GSK598809, and placebo infusion + placebo drug. A placebo is a pill or liquid infusion which contains no drug or alcohol; it is a dummy version. Therefore it is administered in the same way that either the study drug or ethanol is depending on which placebo it is. All study drugs are administered in a random order and both the doctor and the participant are not aware of the treatment combination. However treatment combinations will be available at the end of the study or in case of an emergency. GSK598809 is administered orally and alcohol is administered per infusion. The duration of the infusion is 5 hours, during which approximately 75 grams of alcohol is infused, which is comparable to less than one bottle of wine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• Generally healthy.

• Occasional non-daily smokers.

• Willing to use appropriate contraception method.

• Weight more than 50 kg.

• BMI within the range 18 - 30 kg/m2.

Exclusion Criteria:

• Pregnant or breast feeding female.

• Daily smoker.

• Asthma or a history of asthma.

• Abuse of drugs or alcohol.

• Psychiatric illness.