AV650 Drug-Drug Interaction Study

NCT ID: NCT00456560

Last Updated: 2007-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

AV650

Intervention Type: DRUG

Fluvoxamine

Intervention Type: DRUG

Paroxetine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avigen

INDUSTRY

Sponsor Role: lead

Locations

Covance Global Clinical Pharmacology Inc.

San Diego, California, United States

Countries

United States

Other Identifiers

AV650-019

Identifier Type: -

Identifier Source: org_study_id