Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
|ClinicalTrials.gov Identifier: NCT00381433|
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : July 8, 2009
|Condition or disease||Intervention/treatment||Phase|
|Encephalitis||Drug: AVI-4065 Injection||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration|
|Study Start Date :||September 2006|
|Primary Completion Date :||October 2006|
|Study Completion Date :||June 2009|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381433
|United States, Washington|
|Tacoma, Washington, United States, 98418|
|Principal Investigator:||Paula M Shaw, MD||NW Kinetics|