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AV650 Drug-Drug Interaction Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456560
Recruitment Status : Completed
First Posted : April 5, 2007
Last Update Posted : September 17, 2007
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: AV650 Drug: Fluvoxamine Drug: Paroxetine Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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
Study Start Date : April 2007
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  1. Pharmacokinetics of AV650

Secondary Outcome Measures :
  1. Safety and tolerability of AV650
  2. Genetic contribution, if any, to AV650 metabolism

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456560

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United States, California
Covance Global Clinical Pharmacology Inc.
San Diego, California, United States, 92123
Sponsors and Collaborators
Layout table for additonal information Identifier: NCT00456560    
Other Study ID Numbers: AV650-019
First Posted: April 5, 2007    Key Record Dates
Last Update Posted: September 17, 2007
Last Verified: September 2007
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors