Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration|
- To determine if the study drug penetrates the blood brain barrier following a single intravenous dose, and if so, the associated CSF, plasma and urine pharmacokinetics.
|Study Start Date:||September 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
AVI-4020 Injection, a phosphorodiamidate Morpholino oligomer (PMO), was found to cross the blood-brain barrier during a study of patients with presumptive West Nile virus disease. AVI-4065, which was designed to target HCV, is also a PMO; its ability to cross the blood-brain barrier is unknown. As the incidence of HCV disease has grown, the knowledge base of this disease has likewise increased.
Encephalopathy is a recognized consequence in some patients with HCV infection. In this study, a single dose of AVI-4065 will be subcutaneously injected, and samples collected to determine if this drug crosses the blood-brain barrier. If it does, then additional investigations could be performed in people with HCV disease in which the brain is affected.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381433
|United States, Washington|
|Tacoma, Washington, United States, 98418|
|Principal Investigator:||Paula M Shaw, MD||NW Kinetics|