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

• ClinicalTrials.gov Identifier: NCT00343148
• Recruitment Status: Completed
• First Posted: June 22, 2006
• Last Update Posted: July 8, 2009
• Sponsor: Sarepta Therapeutics, Inc.
• Information provided by: Sarepta Therapeutics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neoplasms	Drug: AVI-4126 Injection (RESTEN-NG®)	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 6 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pharmacokinetic Study of AVI-4126 in Cerebral Spinal Fluid Among Healthy Adult Males Following Intravenous Administration
• Study Start Date: June 2006
• Actual Primary Completion Date: June 2006
• Actual Study Completion Date: June 2009

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Safety
2. Tolerability

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes 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

Locations

United States, Washington

NW Kinetics

Tacoma, Washington, United States, 98418

Sponsors and Collaborators

Sarepta Therapeutics, Inc.

Investigators

• Principal Investigator: Paula M Shaw, MD; NW Kinetics

More Information

• ClinicalTrials.gov Identifier: NCT00343148
• Other Study ID Numbers: AVI-4126-21a
• First Posted: June 22, 2006
• Last Update Posted: July 8, 2009
• Last Verified: July 2009