Trials / Completed
CompletedNCT00381433
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (planned)
- Sponsor
- Sarepta Therapeutics, Inc. · Industry
- Sex
- Male
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AVI-4065 Injection |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2006-10-01
- Completion
- 2009-06-01
- First posted
- 2006-09-27
- Last updated
- 2009-07-08
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00381433. Inclusion in this directory is not an endorsement.