NCT01036061

GSK618334 Repeat Dose Study

A Placebo-controlled, Single Blind, Randomized Two Part Study Toinvestigate the Tolerability, Pharmacokinetics, and brainDopamine D3 Receptor Occupancy of Increasing Repeat Doses ofGSK618334 for up to 21 Days in Healthy Volunteers.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The proposed study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of repeated oral doses of GSK618334 in healthy male and female volunteers.

Detailed description

GSK618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. This study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of GSK618334 in healthy male and female volunteers. The effect of food on a single oral dose of GSK618334 will also be evaluated. Another portion of this study will investigate dopamine type 3 receptor binding in the human brain by PET scan before and after repeated doses of GSK618334.

Conditions

• Substance Dependence

Interventions

Type	Name	Description
DRUG	GSK618334 Low Dose	GSK618334 low dose
DRUG	GSK618334 PET subjects	PET subjects
DRUG	GSK618334 Medium Dose	Medium Dose
DRUG	GSK618334 High Dose	GSK618334 High Dose

Timeline

• Start date: 2009-09-28
• Primary completion: 2010-02-17
• Completion: 2010-02-17
• First posted: 2009-12-21
• Last updated: 2017-06-22

Locations

1 site across 1 country: United Kingdom