Trial | NCT00364039  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    30
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.
Study Started
Aug 31
2006
Last Update
Feb 28
2007
Estimate

Drug AV650

Criteria 

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
No Results Posted