NCT00364039

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
Last Updated

February 28, 2007

Status Verified

February 1, 2007

First QC Date

August 14, 2006

Last Update Submit

February 27, 2007

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

  • Safety

  • Tolerability

Secondary Outcomes (2)

  • Pharmacokinetic profile

  • Sedation and reaction time changes

Interventions

AV650DRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Stephan A. Bart, M.D.

    SNBL Clinical Pharmacology Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Last Updated

February 28, 2007

Record last verified: 2007-02

Locations

US(1)