Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid
Phase 1
Completed
- Conditions
- Neoplasms
- Registration Number
- NCT00343148
- Lead Sponsor
- Sarepta Therapeutics, Inc.
- Brief Summary
Because AVI-4020 Injection was found to cross the blood-brain barrier, and because AVI-4126 (RESTEN-NG) has potential medical benefit to people with a variety of diseases, including cancers, this study is being performed to find out if AVI-4126 also crosses the blood-brain barrier. If it does, then additional investigations could be performed, such as in people with certain types of cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 6
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Safety Tolerability
Trial Locations
- Locations (1)
NW Kinetics
🇺🇸Tacoma, Washington, United States