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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364039
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : February 28, 2007
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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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: AV650 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : August 2006

Primary Outcome Measures :
  1. Safety
  2. Tolerability

Secondary Outcome Measures :
  1. Pharmacokinetic profile
  2. Sedation and reaction time changes

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364039

United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Principal Investigator: Stephan A. Bart, M.D. SNBL Clinical Pharmacology Center Identifier: NCT00364039     History of Changes
Other Study ID Numbers: AV650-012
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: February 28, 2007
Last Verified: February 2007