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

Schizophrenia Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00945503
• Other study ID #: 109731
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2009
• Last updated: July 13, 2017
• Start date: May 19, 2008
• Est. completion date: December 22, 2008

Study information

• Verified date: July 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 22, 2008
• Est. primary completion date: December 22, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• GSK1018921
GSK1018921 is a GT1 recepor antagonist

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PET occupancy with GSK1018921		10 days
Secondary	To assess the safety the AEs and SAEs will be collected during the study such as vital signs, physical exams and laboratory safety tests.		10 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 109731 can be found on the GSK Clinical Study Register.