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AVI-4065 Injection

Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid

Ensayo de Sarepta Therapeutics, Inc. en Encephalitis (del registro, en inglés).

Fase

Fase 1

Estado

Completado

Participantes

12

previstos

Centros

1

Fin del objetivo primario

oct 2006

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en sep 2006.

Qué mide

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. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroAVI-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.

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Ficha completa en ClinicalTrials.gov (NCT00381433), actualizada en jul 2009.