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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014