Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.

GlaxoSmithKline12 enrolled

Overview

A PET study using \[11c\]GSK931145 to characterise the exposure-occupancy relationship over time for GSK1018921.

This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The primary aim of this study is to describe the relationship between plasma concentrations and brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy estimates.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Schizophrenia

Interventions

GSK1018921DRUG

GSK1018921 is a GT1 recepor antagonist

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

* Inclusion criteria: * Healthy male subjects * Age: 18-55 years * No history of physical, neurological or mental illness * Exclusion criteria * History of claustrophobia or inability to lie still in the PET camera for at least 2 hours * Cardiac pacemakers or metal implants in the body that contraindicate MRI scan. * History of regular alcohol consumption (weekly intake \>21 units) within the previous six months.

Locations (1)

GSK Investigational Site

Barcelona, Spain

Outcomes

Primary Outcomes

PET occupancy with GSK1018921

Time frame: 10 days

Secondary Outcomes

To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests.

Time frame: 10 days

Data from ClinicalTrials.gov

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