AV650 Drug-Drug Interaction Study

NCT00456560 | Completed Phase 1

• 1 other identifier: AV650-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of AV650

Secondary Outcomes (2)

• Safety and tolerability of AV650

• Genetic contribution, if any, to AV650 metabolism

Interventions

AV650 DRUG

Fluvoxamine DRUG

Paroxetine DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avigen: lead

Study Sites (1)

Covance Global Clinical Pharmacology Inc.

San Diego, California, 92123, United States

Location

MeSH Terms

Interventions

Fluvoxamine; Paroxetine

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: April 1, 2007
• Study Completion: May 1, 2007
• Last Updated: September 17, 2007

Record last verified: 2007-09

Locations

US (1)