Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2007-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects Depressive Disorder and Anxiety Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK163090

one infusion only

Group Type ACTIVE_COMPARATOR

GSK163090

Intervention Type DRUG

Interventions

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GSK163090

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes