Alcohol Interaction Study
A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 11, 2009
CompletedFirst Submitted
Initial submission to the registry
December 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2009
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedJune 27, 2017
June 1, 2017
2 months
December 17, 2009
June 26, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
pre and post study drug administration
Secondary Outcomes (3)
alcohol level
during and post alcohol administration
blood level of GSK1144814
pre and post study drug administration
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
throughout the study pre- and post dose
Study Arms (2)
GSK1144814
EXPERIMENTALSubjects will receive either GSK1144814 or placebo at each treatment arm.
placebo
PLACEBO COMPARATORSubjects will receive either GSK1144814 or placebo at each treatment arm.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Leiden, 2333 CL, Netherlands
Related Publications (1)
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.
PMID: 23067311BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2009
First Posted
August 13, 2010
Study Start
November 11, 2009
Primary Completion
December 30, 2009
Study Completion
December 30, 2009
Last Updated
June 27, 2017
Record last verified: 2017-06