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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00364039
• Date of registration: 14/08/2006
• Primary sponsor: Avigen
• Public title: Study to Examine the Safety, Tolerability, and Pharmacokinetics of AV650
• Scientific 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
• Date of first enrolment: August 2006
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00364039
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Countries of recruitment

United States

Contacts

• Name: Stephan A. Bart, M.D.
• Affiliation: SNBL Clinical Pharmacology Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: AV650

Primary Outcome(s)

Safety

Tolerability

Secondary Outcome(s)

Pharmacokinetic profile

Sedation and reaction time changes

Secondary ID(s)

AV650-012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors