AV650 Drug-Drug Interaction Study

Official Title: “A Phase I, Randomized, Two-Period, Single-Center Study to Assess the Effect of CYP2D6 and CYP2C19 Inhibitors on a Single Oral Dose of AV650 (300 mg) in Healthy Subjects”

The purpose of this study is to evaluate the effects that paroxetine and fluvoxamine have on the way the body distributes, breakdowns and eliminates AV650. In addition, information about any side effects that may occur will also be collected.

Intervention(s) in this Clinical Trial

• Drug: AV650
• Drug: Fluvoxamine
• Drug: Paroxetine

Primary Measures

• Pharmacokinetics of AV650

Secondary Measures

• Safety and tolerability of AV650
• Genetic contribution, if any, to AV650 metabolism

Inclusion Criteria:

• BMI between 18.5 to 29.9 kg/m2
• In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
• Clinical laboratory evaluations within the reference range for the test laboratory
• Negative test for selected drugs of abuse at Screening
• Negative HBsAg and HIV antibody screens
• Females of childbearing potential must be surgically sterile, post-menopausal for at least one year, or using and effective method of contraception; females of child bearing potential must have a negative serum pregnancy test at Screening and Day -1
• Males must be either sterile or agree to use an approved method of contraception
• Able to comprehend and willing to sign an Informed Consent Form

Exclusion Criteria:

• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, gastrointestinal, urological, neurological, psychiatric disorders, or cancer
• History of inflammatory arthritis
• History of symptomatic hypotension
• History of severe physical injury, direct impact trauma, or neurological trauma within 6 months
• History of seizure disorders
• History of bipolar or major depressive disorder
• History of hypersensitivity or allergies to any drug compound
• Known intolerance to benzodiazepines
• Known intolerance to active and/or inactive ingredients in fluvoxamine or paroxetine
• History of stomach or intestinal surgery or resection, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed
• History or presence of an abnormal ECG
• History of alcoholism, drug abuse, or drug addiction
• Use of any nicotine-containing or nicotine-replacement products within 6 months of Day -1
• Participation in any other investigational study drug trial within 90 days of Day -1
• Use of any prescription medications/products within 3 months of Day 1 unless deemed acceptable by the PI
• Received any vaccination or immunization within 1 month of Day -1
• Use of any over-the-counter, non-prescription preparations within 7 days of Day -1
• Use of alcohol-containing, grapefruit-containing, or caffeine-containing foods or beverages with 72 hours of Day -1
• Poor peripheral venous access
• Donation of blood within 3 months of Day -1 or of plasma within 2 weeks of Screening
• Receipt of blood products within 2 months of Day 1
• Female subjects who are pregnant or nursing
• Any acute or chronic condition that, in the opinion of the PI, would limit the subject's ability to complete and/or participate in this clinical study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Avigen Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00456560

Study ID Number: AV650-019

ClinicalTrials.gov Identifier: NCT00456560

Health Authority: United States: Food and Drug Administration