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Completed

NCT Number: NCT00945503

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

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

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Barcelona, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

GSK1018921

Drug

GSK1018921 is a GT1 recepor antagonist

Primary outcomes

  1. PET occupancy with GSK1018921

    Time frame: 10 days

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Adaptive PET Study in Healthy Volunteers Using [11C]GSK931145 to Establish the Relationship of Glycine Transporter 1 Occupancy by GSK1018921 to Plasma Concentrations Over Time.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 24, 2009
Registry last updated
Jul 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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