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

Healthy Subjects Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435695
• Other study ID #: HTP103265
• Status: Completed
• Phase: Phase 1
• First received: February 13, 2007
• Last updated: May 31, 2012
• Start date: November 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Depressive Disorder and Anxiety Disorders
• Healthy Subjects

Intervention

Drug:
• GSK163090

Locations

Country	Name	City	State
Canada	GSK Investigational Site	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090		throughout the study	No
Secondary	Vitals signs ECGs Clinical Laboratory test results		throughout the study	No