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

This study has been completed.
Sponsor:
Information provided by:
Avigen
ClinicalTrials.gov Identifier:
NCT00364039
First received: August 14, 2006
Last updated: February 27, 2007
Last verified: February 2007
History of Changes
  Purpose

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 Intervention Phase
Healthy Subjects
 Drug: AV650
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Avigen:

Primary Outcome Measures:
  • Safety
  • Tolerability

Secondary Outcome Measures:
  • Pharmacokinetic profile
  • Sedation and reaction time changes

Estimated Enrollment: 30
Study Start Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364039

Locations
United States, Maryland
SNBL Clinical Pharmacology Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Avigen
Investigators
Principal Investigator: Stephan A. Bart, M.D. SNBL Clinical Pharmacology Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00364039     History of Changes
Other Study ID Numbers: AV650-012
Study First Received: August 14, 2006
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 23, 2013