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

NCT00343148 | Completed Phase 1

• 1 other identifier: AVI-4126-21a
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Safety

• Tolerability

Interventions

AVI-4126 Injection (RESTEN-NG®) 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 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.

Sponsors & Collaborators

• Sarepta Therapeutics, Inc.: lead

Study Sites (1)

NW Kinetics

Tacoma, Washington, 98418, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

AVI-4126

Study Officials

• Paula M Shaw, MD

  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: June 20, 2006
• First Posted: June 22, 2006
• Study Start: June 1, 2006
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2009
• Last Updated: July 8, 2009

Record last verified: 2009-07

Locations

US (1)