NCT00937846

Brain Uptake of GSK1034702: a Positron Emission Tomography (PET) Scan Study

An Open Label Positron Emission Tomography (PET) Study to Investigate Brain Penetration by [Carbonyl-11C] GSK1034702 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 35 Years – 55 Years
• Healthy volunteers: Accepted

Summary

GSK1034702 is being developed for improving cognitive impairment in diseases such as Alzheimer's disease and schizophrenia. This study will be done in healthy men to investigate how much of the study drug gets into the brain. This will be done using Positron Emission Tomography (PET).

Detailed description

This is an open label, single dose, non-randomized PET study in healthy male subjects to ascertain if GSK1034702 is crossing the blood-brain barrier to enable it to elicit a central effect. GSK1034702 has been shown in vitro to be a substrate for human Pgp, therefore the distribution of GSK1034702 into human brain could be adversely affected. This use of PET in conjunction with radioactively labelled GSK1034702 will help ascertain the role Pgp plays in limiting brain penetration in the presence and absence of a pharmacological relevant oral non labelled dose of 5 mg. Subjects will have an MRI scan to aid definition of brain anatomy, a baseline PET scan and a post-dose PET scan. For each subject the study will consist of at least three visits; screening visit, scanning day and follow-up.

Conditions

• Cognitive Disorders

Interventions

Type	Name	Description
DRUG	GSK1034702	Single oral 5 mg dose in liquid formulation

Timeline

• Start date: 2009-07-15
• Primary completion: 2009-08-28
• Completion: 2009-08-28
• First posted: 2009-07-13
• Last updated: 2017-06-27

Locations

2 sites across 1 country: United Kingdom