Back to resultsPharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
Primary Purpose
Encephalitis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AVI-4065 Injection
Sponsored by
About this trial
This is an interventional treatment trial for Encephalitis focused on measuring HCV, Hepatitis C virus
Eligibility Criteria
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.
Sites / Locations
- NW Kinetics
Outcomes
Primary Outcome Measures
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
Safety
Tolerability
Full Information
NCT ID
NCT00381433
First Posted
September 25, 2006
Last Updated
July 6, 2009
Sponsor
Sarepta Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00381433
Brief Title
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
Official Title
Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sarepta Therapeutics, Inc.
4. Oversight
5. Study Description
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Encephalitis
Keywords
HCV, Hepatitis C virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AVI-4065 Injection
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety
Title
Tolerability
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula M Shaw, MD
Organizational Affiliation
NW Kinetics
Official's Role
Principal Investigator
Facility Information:
Facility Name
NW Kinetics
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98418
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid
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