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Clinical Trial Summary

During a clinical study of people with severe West Nile virus infections, it was determined that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of drug that goes across the blood-brain barrier and the drug levels measured in both the blood and urine.

The objective of this study is to find out how much and how fast this drug crosses this barrier.


Clinical Trial Description

AVI-4020 was designed to interfere with West Nile virus translation, and has been shown to cross the blood-brain barrier in both normal and inflamed meninges in a clinical study in patients with severe West Nile virus disease.

At issue, is whether this observation is limited to AVI-4020 PMO drug, or is observed with other PMO drugs. This study is one of three to assess the specific ability of PMO drugs to cross the blood-brain barrier, using similar dosing, and PK assessment time points. In order to rigorously assess the pharmacokinetics, this study is being performed in healthy volunteers at a single point in time.

The ability of other PMO drugs to cross the blood-brain barrier will set the stage for future studies that exploit this product characteristic. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00387283
Study type Interventional
Source Sarepta Therapeutics
Contact
Status Completed
Phase Phase 1
Start date October 2006
Completion date June 2009

See also
  Status Clinical Trial Phase
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Completed NCT00097006 - Retrovirus Epidemiology Donor Study-II (REDS-II) N/A
Completed NCT00138463 - West Nile Virus Natural History N/A
Completed NCT00068055 - IVIG - West Nile Encephalitis: Safety and Efficacy Phase 1/Phase 2
Completed NCT00069303 - Natural History of West Nile Virus Infection N/A
Withdrawn NCT04371003 - Prospective Investigation of Oxidative Stress in West Nile Virus Infection
Completed NCT05294003 - West Nile Virus Seroprevalence Under Bird Ringers
Completed NCT02186626 - Evaluating the Safety and Immunogenicity of a Live Attenuated West Nile Virus Vaccine for West Nile Encephalitis in Adults 50 to 65 Years of Age Phase 1
Completed NCT00515385 - A Trial to Evaluate the Safety of a Single Intravenous Infusion of MGAWN1 in Healthy Adults Phase 1