AV650 Drug-Drug Interaction Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Paroxetine; Drug: AV650; Drug: Fluvoxamine

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Covance Global Clinical Pharmacology Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacokinetics of AV650

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Avigen

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: April 3, 2007
• First Submitted That Met QC Criteria: April 4, 2007
• First Posted (Estimate): April 5, 2007

Study Record Updates

• Last Update Posted (Estimate): September 17, 2007
• Last Update Submitted That Met QC Criteria: September 13, 2007
• Last Verified: September 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Paroxetine; Fluvoxamine
• Other Study ID Numbers: AV650-019