NCT00435695

Brief Summary

The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called \[11C\]-WAY100635.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 15, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 4, 2012

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

February 13, 2007

Last Update Submit

May 31, 2012

Conditions

Healthy SubjectsDepressive Disorder and Anxiety Disorders

Keywords

PET scanhealthy males

Outcome Measures

Primary Outcomes (1)

  • Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090

    throughout the study

Secondary Outcomes (1)

  • Vitals signs ECGs Clinical Laboratory test results

    throughout the study

Study Arms (1)

GSK163090

ACTIVE COMPARATOR

one infusion only

Drug: GSK163090

Interventions

GSK163090DRUG
GSK163090

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects, aged 18-45 years Body weight \> 50 kg
  • Non-Smoker
  • Normal ECG, heart rate and blood pressure

You may not qualify if:

  • History of any cardiac disease
  • History of regular alcohol consumption averaging \>14 drinks/week
  • Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
  • Positive for Hepatitis B and C, and HIV.
  • History of drug abuse.
  • Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
  • Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
  • Suffers from claustrophobia
  • History or presence of neurological or psychiatric conditions
  • Presence of a cardiac pacemaker or other implanted electronic device or metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Toronto, Ontario, M5T 1R8, Canada

Location

MeSH Terms

Conditions

Depressive DisorderAnxiety Disorders

Interventions

1-(3-(2-(4-(2-methyl-5-quinolinyl)-1-piperazinyl)ethyl)phenyl)-2-imidazolidinone

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2007

First Posted

February 15, 2007

Study Start

November 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-05

Locations

CA(1)