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Pharmacokinetic Study of a Single Dose of AVI-4065 in Cerebral Spinal Fluid

This study has been completed.

Sponsored by: AVI BioPharma
Information provided by: AVI BioPharma
ClinicalTrials.gov Identifier: NCT00381433
  Purpose

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.


Condition Intervention Phase
Encephalitis
Drug: AVI-4065 Injection
Phase I

MedlinePlus related topics:   Encephalitis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:   Pharmacokinetic Study of AVI-4065 in Cerebral Spinal Fluid Among Healthy Adult Males Following Subcutaneous Administration

Further study details as provided by AVI BioPharma:

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

Estimated Enrollment:   12
Study Start Date:   September 2006
Study Completion Date:   October 2006

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.

  Eligibility
Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00381433

Locations
United States, Washington
NW Kinetics    
      Tacoma, Washington, United States, 98418

Sponsors and Collaborators
AVI BioPharma

Investigators
Principal Investigator:     Paula M Shaw, MD     NW Kinetics    
  More Information

Study ID Numbers:   AVI-4065-21c
First Received:   September 25, 2006
Last Updated:   March 21, 2007
ClinicalTrials.gov Identifier:   NCT00381433
Health Authority:   United States: Food and Drug Administration

Keywords provided by AVI BioPharma:
HCV  
Hepatitis C virus  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Central Nervous System Infections
Central Nervous System Diseases
Healthy
Hepatitis C
Brain Diseases
Encephalitis

Additional relevant MeSH terms:
Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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