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| Sponsored by: |
AVI BioPharma, Inc. |
|---|---|
| Information provided by: | AVI BioPharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT00381433 |
Purpose
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. 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 severe forms of HCV disease in which the brain is affected.
| Condition | Intervention | Phase |
|---|---|---|
|
Encephalitis |
Drug: AVI-4065 Injection |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration |
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2006 |
| Study Completion Date: | October 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | AVI-4065-21c |
| Study First Received: | September 25, 2006 |
| Last Updated: | March 21, 2007 |
| ClinicalTrials.gov Identifier: | NCT00381433 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
HCV Hepatitis C virus |
|
Virus Diseases Hepatitis Central Nervous System Infections Central Nervous System Diseases |
Healthy Hepatitis C Brain Diseases Encephalitis |
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Virus Diseases Central Nervous System Infections Nervous System Diseases Central Nervous System Diseases |
Central Nervous System Viral Diseases Brain Diseases Encephalitis |