Back to resultsAlcohol Interaction Study
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
single dose
Sponsored by
About this trial
This is an interventional other trial for Alcoholism focused on measuring alcohol, drug interaction, pharmacodynamic
Eligibility 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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
GSK1144814
placebo
Arm Description
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Outcomes
Primary Outcome Measures
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Secondary Outcome Measures
alcohol level
blood level of GSK1144814
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01181908
Brief Title
Alcohol Interaction Study
Official Title
A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
November 11, 2009 (Actual)
Primary Completion Date
December 30, 2009 (Actual)
Study Completion Date
December 30, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
alcohol, drug interaction, pharmacodynamic
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1144814
Arm Type
Experimental
Arm Description
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive either GSK1144814 or placebo at each treatment arm.
Intervention Type
Drug
Intervention Name(s)
single dose
Intervention Description
Subjects will receive a single dose of GSK1144814 or placebo.
Primary Outcome Measure Information:
Title
pharmacodynamic measures for various psychomotor/cognition function and subjective effects
Time Frame
pre and post study drug administration
Secondary Outcome Measure Information:
Title
alcohol level
Time Frame
during and post alcohol administration
Title
blood level of GSK1144814
Time Frame
pre and post study drug administration
Title
safety and tolerability as measured by adverse events, vital signs, clinical laboratory measurements and validated clinical assessment scales
Time Frame
throughout the study pre- and post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Leiden
ZIP/Postal Code
2333 CL
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
23067311
Citation
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.
Results Reference
background
Learn more about this trial
Alcohol Interaction Study
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