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

Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms
• Intervention / Treatment: Drug: AVI-4126 Injection (RESTEN-NG®)

• Study Type: Interventional
• Enrollment: 6
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Safety
Tolerability

Collaborators and Investigators

• Sponsor: Sarepta Therapeutics, Inc.
• Investigators: Principal Investigator: Paula M Shaw, MD, NW Kinetics

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): June 1, 2006
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: June 20, 2006
• First Submitted That Met QC Criteria: June 20, 2006
• First Posted (Estimate): June 22, 2006

Study Record Updates

• Last Update Posted (Estimate): July 8, 2009
• Last Update Submitted That Met QC Criteria: July 6, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: AVI-4126-21a