Alcohol Interaction Study

NCT ID: NCT01181908

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-11

Study Completion Date

2009-12-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcoholism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GSK1144814

Subjects will receive either GSK1144814 or placebo at each treatment arm.

Group Type EXPERIMENTAL

single dose

Intervention Type DRUG

Subjects will receive a single dose of GSK1144814 or placebo.

placebo

Subjects will receive either GSK1144814 or placebo at each treatment arm.

Group Type PLACEBO_COMPARATOR

single dose

Intervention Type DRUG

Subjects will receive a single dose of GSK1144814 or placebo.

Interventions

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single dose

Subjects will receive a single dose of GSK1144814 or placebo.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Leiden, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type BACKGROUND
PMID: 23067311 (View on PubMed)

Other Identifiers

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113476

Identifier Type: -

Identifier Source: org_study_id

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