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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343148
• Other study ID #: AVI-4126-21a
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2006
• Last updated: July 6, 2009
• Start date: June 2006
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Sarepta Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2009
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• AVI-4126 Injection (RESTEN-NG®)

Locations

Country	Name	City	State
United States	NW Kinetics	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Sarepta Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety
Secondary	Tolerability