Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00364039
• Lead Sponsor: Avigen

Brief Summary

The purpose of this study is to determine the safety and tolerability of AV650 in healthy subjects given single and multi-doses under fasted and fed conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-15
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-27
• Last Update Posted: 2007-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Non-smoking
• Body mass index between 18.5 and 29.9 kg/m2 or body mass index greater than 29.9 kg/m2 with good to excellent body fat percentage

Exclusion Criteria

• Known hypersensitivity to lidocaine or non-steroidal anti-inflammatory agents (NSAIDS)
• History of clinically significant cardiovascular, pulmonary, endocrine, neurological, metabolic, or psychiatric disease
• History of HIV or Hepatitis B
• History of symptomatic hypotension
• History of mental illness, drug addiction, drug abuse or alcoholism
• History of cancer
• History of inflammatory arthritis (rheumatoid, lupus, psoriatic arthritis)
• Current use of immunosuppressive therapy (systemic steroids, cyclosporine) or use of nasal or topical steroids
• History of gastric or duodenal ulcer disease
• History of severe physical injury, direct impact trauma or neurological trauma within 6 months of Study Day 1
• Female subjects who are pregnant or nursing
• Have donated blood within 90 days of Study Day -1
• Have received an investigational drug within 90 days of Screening
• Require regular use of antihistamines, H2 blockers (such as cimetidine, ranitidine), TCAs or SSRIs or who have taken these medications witin 14 days of Study Day 1

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Tolerability

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetic profile
Sedation and reaction time changes

Trial Locations

Locations (1)

SNBL Clinical Pharmacology Center; 🇺🇸 Baltimore, Maryland, United States