AV650 Drug-Drug Interaction Study

This study has been completed.
Sponsor:
Information provided by:
Avigen
ClinicalTrials.gov Identifier:
NCT00456560
First received: April 3, 2007
Last updated: September 13, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Healthy
Drug: AV650
Drug: Fluvoxamine
Drug: Paroxetine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Avigen:

Primary Outcome Measures:
  • Pharmacokinetics of AV650

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

Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456560

Locations
United States, California
Covance Global Clinical Pharmacology Inc.
San Diego, California, United States, 92123
Sponsors and Collaborators
Avigen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00456560     History of Changes
Other Study ID Numbers: AV650-019
Study First Received: April 3, 2007
Last Updated: September 13, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Paroxetine
Fluvoxamine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on August 25, 2014