A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers

July 18, 2017 updated by: GlaxoSmithKline

A Randomised, Placebo-controlled, Double-dummy, Crossover Design Study to Investigate the Changes of fMRI BOLD Activation Induced by Emotional Activation Paradigms Following Single Doses of GSK561679 and Lorazepam (Comparator) in Healthy Subjects

This study will be conducted in healthy volunteers to investigate the effect of single dose GSK561679 on the changes of brain activation, as it compares to an active comparator, lorazepam.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Healthy males
  • Non-smokers
  • Body weight 50 kg (110 lbs) or higher, and BMI within the range 19-29.9 kg/m2
  • Normal ECG.

Exclusion Criteria:

  • 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.
  • History or current diagnosis of acute narrow angle glaucoma.
  • Left handed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Experimental: GSK561679 arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.
Active Comparator: lorazepam arm
There are single dose treatment arms of GSK561679, lorazepam as well as placebo.
Drug: single dose
Subjects will receive single doses of GSK561679, lorazepam, or placebo at each treatment session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Differences in fMRI brain activation (BOLD) response in specific brain regions
Time Frame: conducted the duration of the study
conducted the duration of the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Physiologic changes
Time Frame: during & after fMRI session
during & after fMRI session
Visual Analogue Scale measurement of physical reactions
Time Frame: duration of study
duration of study
Blood level of GSK561679
Time Frame: collected during fMRI session
collected during fMRI session
Vital signs & ECG recording
Time Frame: duration of the study
duration of the study
Lab tests for blood & urine
Time Frame: throughout the study
throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2007

Primary Completion (Actual)

May 14, 2009

Study Completion (Actual)

May 14, 2009

Study Registration Dates

First Submitted

August 6, 2007

First Submitted That Met QC Criteria

August 6, 2007

First Posted (Estimate)

August 8, 2007

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRS105510

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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