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Completed

NCT Number: NCT00364039

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

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AV650

Drug

Primary outcomes

  1. Safety

  2. Tolerability

Secondary outcomes

  1. Pharmacokinetic profile

  2. Sedation and reaction time changes

Sponsors and collaborators

Lead sponsor

Avigen

Industry

Registry information

Official study 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

Important dates

Study start
2006
First posted
Aug 15, 2006
Registry last updated
Feb 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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