- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381433
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
Study Overview
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.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Tacoma, Washington, United States, 98418
- NW Kinetics
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult males 18 years to 64 years of age;
- Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range)
- Signed and dated written informed consent form; and
- Willing to participate in all study activities and all requirements, including effective contraception (viz., a double-barrier method) during the 7-day study surveillance period.
Exclusion Criteria:
- Hematology, serum chemistry (exclusive of electrolytes), and urinalysis laboratory test values >2 times upper limits of normal or anemia (hemoglobulin <11 g/dL), leukopenia (total white blood count <3,000/µL or total neutrophils <1,500/ µL) or thrombocytopenia (platelets <100,000/µL). Electrolytes and coagulation values exceeding normal ranges are to be excluded.
- Body Mass Index (BMI) >35.
- Calculated creatinine clearance (by the Cockroft and Gault Formula) <70 mL/min, based on age and gender.
- Positive HIV-1 or HIV-2 serology.
- Positive HCV serology and/or positive plasma HCV-RNA status.
- Positive HBsAg or HBcAb status.
- Solid or hematopoetic organ transplant recipient.
- Active illness or recent illness within 30 days of the first dose of study drug.
- History of any of the following: brain injury, neoplasm, chronic or migraine headaches, cancer, meningitis or hydrocephalus.
- Usage of any prescribed, over-the-counter or illicit drug(s) within 30 days of study drug administration. Use of herbal remedies and/or supplements at the discretion of the Investigator.
- Unwilling to practice effective contraception during the study period.
- Participation in any clinical interventional trial within the previous 6 months.
- Positive drug urine screen.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Safety
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Tolerability
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Paula M Shaw, MD, NW Kinetics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AVI-4065-21c
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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