MedDataX Logo

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

NCT ID: NCT00364039

Last Updated: 2007-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Subjects

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AV650

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Avigen

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Stephan A. Bart, M.D.

Role: PRINCIPAL_INVESTIGATOR

SNBL Clinical Pharmacology Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

SNBL Clinical Pharmacology Center

Baltimore, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AV650-012

Identifier Type: -

Identifier Source: org_study_id