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

An Open Label, Non-randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435695

Enrollment

Registered

2007-02-15

Start date

2006-11-30

Completion date

2007-12-31

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder and Anxiety Disorders, Healthy Subjects

Keywords

PET scan, healthy males

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.

Interventions

DRUGGSK163090

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090	throughout the study

Secondary

Measure	Time frame
Vitals signs ECGs Clinical Laboratory test results	throughout the study

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026