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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00945503

Enrollment

Registered

2009-07-24

Start date

2008-05-19

Completion date

2008-12-22

Last updated

2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Glycine Tranporter, MRI, PET

Brief summary

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

Detailed 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.

Interventions

DRUGGSK1018921

GSK1018921 is a GT1 recepor antagonist

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
PET occupancy with GSK1018921	10 days

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026