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

This study has been completed.
Sponsor:
Information provided by:
Sarepta Therapeutics
ClinicalTrials.gov Identifier:
NCT00343148
First received: June 20, 2006
Last updated: July 6, 2009
Last verified: July 2009
  Purpose

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 Intervention Phase
Neoplasms
Drug: AVI-4126 Injection (RESTEN-NG®)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration

Resource links provided by NLM:


Further study details as provided by Sarepta Therapeutics:

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: 6
Study Start Date: June 2006
Study Completion Date: June 2009
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
  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: NCT00343148

Locations
United States, Washington
NW Kinetics
Tacoma, Washington, United States, 98418
Sponsors and Collaborators
Sarepta Therapeutics
Investigators
Principal Investigator: Paula M Shaw, MD NW Kinetics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00343148     History of Changes
Other Study ID Numbers: AVI-4126-21a
Study First Received: June 20, 2006
Last Updated: July 6, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014