Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2009-11-11
2009-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
DOUBLE
Study Groups
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GSK1144814
Subjects will receive either GSK1144814 or placebo at each treatment arm.
single dose
Subjects will receive a single dose of GSK1144814 or placebo.
placebo
Subjects will receive either GSK1144814 or placebo at each treatment arm.
single dose
Subjects will receive a single dose of GSK1144814 or placebo.
Interventions
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single dose
Subjects will receive a single dose of GSK1144814 or placebo.
Eligibility Criteria
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Inclusion Criteria
* Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
* Willing to use appropriate contraception methods
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Leiden, , Netherlands
Countries
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References
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te Beek ET, Hay JL, Bullman JN, Burgess C, Nahon KJ, Klaassen ES, Gray FA, van Gerven JM. Pharmacokinetics and central nervous system effects of the novel dual NK1 /NK3 receptor antagonist GSK1144814 in alcohol-intoxicated volunteers. Br J Clin Pharmacol. 2013 May;75(5):1328-39. doi: 10.1111/bcp.12004.
Other Identifiers
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113476
Identifier Type: -
Identifier Source: org_study_id
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