Status:
COMPLETED
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
Lead Sponsor:
Sarepta Therapeutics, Inc.
Conditions:
Encephalitis
Eligibility:
MALE
18-64 years
Phase:
PHASE1
Brief 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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
End Date :
June 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00381433
Start Date
September 1 2006
End Date
June 1 2009
Last Update
July 8 2009
Active Locations (1)
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1
NW Kinetics
Tacoma, Washington, United States, 98418