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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects; Depressive Disorder and Anxiety Disorders

Treatments: Drug: GSK163090

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435695

HTP103265

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

GSK163090

Active Comparator group

Description:

one infusion only

Treatment:

Drug: GSK163090