None listed
Conditions
Interventions
Oral AV411 (20, 30, or 40 mg) two or three times daily for 24 days
Sponsors
Avigen, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration.-VAS score of 4 cm or higher at screening.-No clinical abnormality in laboratory and urine analyses.-Electrocardiogram within normal limits at screening.-Negative pregnancy test on Study Day 1 for female subjects of childbearing potential.-On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment.-Willing to use barrier contraceptive during the period of the study.
Exclusion criteria
Known hypersensitivity to AV411 or its components.-Conditions which might affect drug absorption, metabolism or excretion.-Untreated mental illness, current drug addiction or abuse or alcoholism.-Donated blood in the past 90 days or have poor peripheral venous access.-Platelets <100,000 mm3 or a history of thrombocytopenia.-Known or suspected chronic liver disease.-GFR <= 90 mL/min/1.73m2 (Cockcroft-Gualt).-Female subjects who are pregnant or nursing mothers.-Received an investigational drug in the past 90 days.-Unable to swallow large capsules.
Outcome results
None listed