This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.
This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
8
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom
Positron Gamma-ray emmision & voxel counts
Brain regions of interest and associated radionuclitide-activity
Time frame: 60 minutes
systemic plasma concentration
serial sampling: GSK356278 concentration expressed as mass per unit of volume
Time frame: 24 hours
Blood pressure - mm/Hg
Standard clinical pharmacology safety monitoring of vital signs
Time frame: 24 hours
ECG - 12-Lead & Telemetry
Standard clinical pharmacology safety monitoring
Time frame: 24 & 72 hours
Heart rate - bpm
Standard clinical pharmacology safety monitoring of vital signs
Time frame: 72 hours
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