West Nile Virus Clinical Trial
Official title:
Pharmacokinetic Study of AVI-4020 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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