Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00381433
Other study ID # AVI-4065-21c
Secondary ID
Status Completed
Phase Phase 1
First received September 25, 2006
Last updated July 6, 2009
Start date September 2006
Est. completion date June 2009

Study information

Verified date July 2009
Source Sarepta Therapeutics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date June 2009
Est. primary completion date October 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 64 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
AVI-4065 Injection


Locations

Country Name City State
United States NW Kinetics Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
Sarepta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Safety
Secondary Tolerability
See also
  Status Clinical Trial Phase
Completed NCT02538094 - tDCS and Cognition in Adults With Multiple Sclerosis or Encephalitis N/A
Completed NCT00031486 - Long Term Treatment of Herpes Simplex Encephalitis (HSE) With Valacyclovir Phase 3
Completed NCT00069303 - Natural History of West Nile Virus Infection N/A
Completed NCT02906631 - Epidemiology and Prognosis of Encephalitis in Intensive Care
Completed NCT02367664 - A Clinical Trial for Inactivated Japanese Encephalitis Vaccine in Healthy Chinese Infants Phase 3
Completed NCT00314132 - Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis. Phase 3
Terminated NCT00927953 - Treatment of West Nile Virus With MGAWN1 Phase 2
Recruiting NCT05393492 - Regulating Emotions and Behaviors After Brain Injury N/A
Terminated NCT04361344 - Neurodegeneration Markers and Neurological Course in Severe Covid-19 Infection N/A
Recruiting NCT04460599 - Neurological Features During COVID19
Recruiting NCT04372615 - The ExTINGUISH Trial of Inebilizumab in NMDAR Encephalitis Phase 2
Completed NCT02714959 - IL-2 in Refractory Autoimmune Encephalitis Phase 1/Phase 2
Completed NCT01041573 - Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population Phase 3
Completed NCT01092507 - A Study of Japanese Encephalitis Chimeric Virus Vaccine Compared With SA14-14-2 Vaccine in Infants and Toddlers Phase 3
Not yet recruiting NCT04722328 - Establishment of Prevention and Control System of Central Nervous System Infection
Recruiting NCT06067750 - Comparison of Narcotrend and Cerebral Function Analysing Monitor in Intensive Care to Monitor Seizures and Deep Sedation
Not yet recruiting NCT06368648 - CoMind Early Feasibility Study
Completed NCT02526550 - Immunogenicity of a Live Attenuated Chimeric JE Vaccine (IMOJEV) as a Booster Dose in Thai Children Primed With CD.JEVAX Phase 4
Completed NCT01694524 - Nervous System Infections Among Patients With Febrile Seizure N/A
Completed NCT04080921 - Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis Phase 1/Phase 2