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

NCT00387283 | Completed Phase 1

• 1 other identifier: AVI-4020-21b
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

West Nile Virus

Keywords

WNV; West Nile virus; WNV meningoencephalitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety, Tolerability

Interventions

AVI-4020 Injection DRUG

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead

Study Sites (1)

NW Kinetics

Tacoma, Washington, 98418, United States

Location

Study Officials

• Paula M Shaw, M.D.

  NW Kinetics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2006
• First Posted: October 13, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: June 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

US (1)