AV650 Drug-Drug Interaction Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: AV650
* Drug: Fluvoxamine
* Drug: Paroxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AV650|nan|
|Drug: Fluvoxamine|nan|
|Drug: Paroxetine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of AV650 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of AV650 |  |  | 
| Genetic contribution, if any, to AV650 metabolism |  |  |