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

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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 23, 2014