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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-19

Study Completion Date

2008-12-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GSK1018921

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.

Group Type EXPERIMENTAL

GSK1018921

Intervention Type DRUG

GSK1018921 is a GT1 recepor antagonist

Interventions

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GSK1018921

GSK1018921 is a GT1 recepor antagonist

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Barcelona, , Spain

Site Status

Countries

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Spain

Study Documents

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