Healthy Subjects Clinical Trial
Official title:
A Phase 1 Double-Blind, Placebo-Controlled Single Center Trial to Assess the Safety, Tolerability and Pharmacokinetics of Single Dose and Multiple Dose Escalations of AV650 in Healthy Subjects
NCT number | NCT00364039 |
Other study ID # | AV650-012 |
Secondary ID | |
Status | Completed |
Phase | Phase 1 |
First received | August 14, 2006 |
Last updated | February 27, 2007 |
Start date | August 2006 |
Verified date | February 2007 |
Source | Avigen |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
Country | Name | City | State |
---|---|---|---|
United States | SNBL Clinical Pharmacology Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Avigen |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | |||
Primary | Tolerability | |||
Secondary | Pharmacokinetic profile | |||
Secondary | Sedation and reaction time changes |
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