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Alcohol Interaction Study

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01181908
First received: December 17, 2009
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Alcoholism
 Drug: single dose
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • pharmacodynamic measures for various psychomotor/cognition function and subjective effects [ Time Frame: pre and post study drug administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • alcohol level [ Time Frame: during and post alcohol administration ] [ Designated as safety issue: No ]
  • blood level of GSK1144814 [ Time Frame: pre and post study drug administration ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK1144814
Subjects will receive either GSK1144814 or placebo at each treatment arm.
 Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo.
Placebo Comparator: placebo
Subjects will receive either GSK1144814 or placebo at each treatment arm.
 Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181908

Locations
Netherlands
GSK Investigational Site
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: E.D. Derilus; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01181908     History of Changes
Other Study ID Numbers: 113476
Study First Received: December 17, 2009
Last Updated: January 27, 2011
Health Authority: Netherlands: Dutch Medical Research in Human Subjects Act (WMO)
Netherlands: Ministry of Health, Welfare and Sports
Netherlands: De Centrale Commissie Mensgebonden Onderzoek
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
alcohol
drug interaction
pharmacodynamic

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013