Pharmacokinetic Study in Cerebral Spinal Fluid After a Single Dose of AVI-4020

July 6, 2009 updated by: Sarepta Therapeutics, Inc.

Pharmacokinetic Study of AVI-4020 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration

During a clinical study of people with severe West Nile virus infections, it was determined that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of drug that goes across the blood-brain barrier and the drug levels measured in both the blood and urine.

The objective of this study is to find out how much and how fast this drug crosses this barrier.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

AVI-4020 was designed to interfere with West Nile virus translation, and has been shown to cross the blood-brain barrier in both normal and inflamed meninges in a clinical study in patients with severe West Nile virus disease.

At issue, is whether this observation is limited to AVI-4020 PMO drug, or is observed with other PMO drugs. This study is one of three to assess the specific ability of PMO drugs to cross the blood-brain barrier, using similar dosing, and PK assessment time points. In order to rigorously assess the pharmacokinetics, this study is being performed in healthy volunteers at a single point in time.

The ability of other PMO drugs to cross the blood-brain barrier will set the stage for future studies that exploit this product characteristic.

Study Type

Interventional

Enrollment

14

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 Hepatitis B 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 dose of AVI-4020, and if it does, the associated CSF, plasma and urine pharmacokinetics

Secondary Outcome Measures

Outcome Measure
Safety, Tolerability

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sarepta Therapeutics, Inc.

Investigators

  • Principal Investigator: Paula M Shaw, M.D., NW Kinetics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

October 11, 2006

First Submitted That Met QC Criteria

October 11, 2006

First Posted (Estimate)

October 13, 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

Keywords

Other Study ID Numbers

  • AVI-4020-21b

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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