Alcohol Interaction Study

Alcoholism Clinical Trial

Official title:

A Study to Investigate the Psychomotor and Cognitive Effects of Alcohol When Co-administered With GSK1144814 or Matching Placebo in Healthy Subjects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181908
• Other study ID #: 113476
• Status: Completed
• Phase: Phase 1
• First received: December 17, 2009
• Last updated: June 26, 2017
• Start date: November 11, 2009
• Est. completion date: December 30, 2009

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 30, 2009
• Est. primary completion date: December 30, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• single dose
Subjects will receive a single dose of GSK1144814 or placebo.

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacodynamic measures for various psychomotor/cognition function and subjective effects		pre and post study drug administration
Secondary	alcohol level		during and post alcohol administration
Secondary	blood level of GSK1144814		pre and post study drug administration
Secondary	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

External Links

•   Results for study 113476 can be found on the GSK Clinical Study Register.