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Pharmacokinetic Study of a Single Dose of AVI-4126 (RESTEN-NG®) in Cerebral Spinal Fluid

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00343148
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : July 8, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: AVI-4126 Injection (RESTEN-NG®) Phase 1

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Study Type : Interventional  (Clinical Trial)
Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration
Study Start Date : June 2006
Actual Primary Completion Date : June 2006
Actual Study Completion Date : June 2009

Primary Outcome Measures :
  1. 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 :
  1. Safety
  2. Tolerability

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00343148

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United States, Washington
NW Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Sarepta Therapeutics, Inc.
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Principal Investigator: Paula M Shaw, MD NW Kinetics
Layout table for additonal information Identifier: NCT00343148    
Other Study ID Numbers: AVI-4126-21a
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: July 8, 2009
Last Verified: July 2009