Alcohol Interaction Study

• Status: Completed
• Trial end date: 2009-12-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.

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

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Ethanol

Criteria

Inclusion Criteria:

• Healthy male and female

• Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2

• Willing to use appropriate contraception methods

Exclusion Criteria:

• Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result

• Any serious medical disorder or condition

• Any history of an endocrine disorder.

• Any clinically significant laboratory abnormality.

• History of psychiatric illness.

• Any history of suicidal attempts or behavior.

• Positive urine drug screen or positive blood alcohol

• Pregnant, nursing or potential to have a child

• Past history of alcohol dependence or abuse.

• History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.

• smokers