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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00468806 |
The purpose of this study is to look at how much of a new drug, GSK598809 binds to specific proteins in the brain and how much stays in the blood over a range of different doses.
Condition | Intervention | Phase |
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Healthy Subjects |
Drug: GSK598809, using [11C]-(+)-PHNO |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | An Open Label Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain Dopamine D3 Occupancy Kinetics, Pharmacokinetics and Safety of Single Oral Doses of GSK598809, Using [11C]-(+)-PHNO as PET Ligand. |
Enrollment: | 25 |
Study Start Date: | April 2007 |
Study Completion Date: | May 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 25 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy male subjects, defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests.
Exclusion Criteria:
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | DAN106589 |
Study First Received: | May 1, 2007 |
Last Updated: | October 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00468806 History of Changes |
Health Authority: | Canada: Health Canada; Canada: Therapetic Products Directorate |
PET scan Health Males |
Dopamine Dopamine Agents Healthy |