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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Schizophrenia

Treatments: Drug: GSK1018921

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945503

109731

Details and patient eligibility

About

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

Full description

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.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 1 patient group

GSK1018921

Experimental group

Description:

All subjects will received a dose of GSK1018921 and will peforme three PET scans using the ligand \[11C\]GSK931145, but in order to obtain adequate sampling of the exposure-time-occupancy curves, a range of doses will be evaluated, and the timing of the post-dose scans will differ between subjects.

Treatment:

Drug: GSK1018921