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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00364039
• Other study ID #: AV650-012
• Status: Completed
• Phase: Phase 1
• First received: August 14, 2006
• Last updated: February 27, 2007
• Start date: August 2006

Study information

• Verified date: February 2007
• Source: Avigen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• AV650

Locations

Country	Name	City	State
United States	SNBL Clinical Pharmacology Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Avigen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Primary	Tolerability
Secondary	Pharmacokinetic profile
Secondary	Sedation and reaction time changes