Alcohol Interaction Study

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Alcoholism

Treatments: Drug: single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181908

113476

Details and patient eligibility

About

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

Full description

The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.

Enrollment: 21 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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21 participants in 2 patient groups, including a placebo group

GSK1144814

Experimental group

Description:

Subjects will receive either GSK1144814 or placebo at each treatment arm.

Treatment:

Drug: single dose

placebo

Placebo Comparator group

Description:

Subjects will receive either GSK1144814 or placebo at each treatment arm.

Treatment:

Drug: single dose