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NCT00381433 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
A Phase 1 study, sponsored by Sarepta Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT00381433 is a Phase 1 study that has completed, run by Sarepta Therapeutics. The registered enrollment target is 12 participants.
The verdict
NCT00381433, a Phase 1 study, has completed, sponsored by Sarepta Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study 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.
Interventions
- DRUG AVI-4065 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2006-09 |
| Est. Completion | 2009-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00381433
The ClinicalTrials.gov registry entry for NCT00381433 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sarepta Therapeutics, which has 33 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which AVI-4065 Injection is the first listed.
NCT00381433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00381433 about?
NCT00381433 is a clinical study titled "Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid". 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 t...
What is the current status of trial NCT00381433?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2006-09. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00381433?
The interventions under investigation include: AVI-4065 Injection (DRUG).
Who is sponsoring clinical trial NCT00381433?
This trial is sponsored by Sarepta Therapeutics, which has 33 total clinical trials registered on ClinicalTrials.gov.
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