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Alcohol Interaction Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01181908
First received: December 17, 2009
Last updated: June 26, 2017
Last verified: June 2017
December 17, 2009
June 26, 2017
November 11, 2009
December 30, 2009   (Final data collection date for primary outcome measure)
pharmacodynamic measures for various psychomotor/cognition function and subjective effects [ Time Frame: pre and post study drug administration ]
Same as current
Complete list of historical versions of study NCT01181908 on ClinicalTrials.gov Archive Site
  • alcohol level [ Time Frame: during and post alcohol administration ]
  • blood level of GSK1144814 [ Time Frame: pre and post study drug administration ]
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.
The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Alcoholism
Drug: single dose
Subjects will receive a single dose of GSK1144814 or placebo.
  • Experimental: GSK1144814
    Subjects will receive either GSK1144814 or placebo at each treatment arm.
    Intervention: Drug: single dose
  • Placebo Comparator: placebo
    Subjects will receive either GSK1144814 or placebo at each treatment arm.
    Intervention: Drug: single dose
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
December 30, 2009
December 30, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01181908
113476
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP