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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 25, 2014