Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Healthy male volunteer, aged 22-55 years.
- Normal blood pressure, laboratory values, and body mass index
- Willing to agree to study procedures & contraception requirements
- Capable of giving written informed consent
Exclusion criteria
- Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
- Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
- Smoker
- Suffers from claustrophobia
- Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)
Trial design
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal