AV650 Drug-Drug Interaction Study

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