Investigation of AV411 in Healthy Subjects

Phase 1

Recruiting

• Conditions: Healthy subjects; Other -

• Registration Number: ACTRN12606000410550
• Lead Sponsor: Avigen, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-09-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Nonsmoking.-No clinical abnormality in laboratory and urine analyses.-Normal renal function Glomerular Filtration Rate (GFR) >90 mL/min.-Liver enzymes less than twice the upper limit of normal.-Electrocardiogram within normal limits at screening.-Willing to use barrier contraceptive during the period of the study.-Negative pregnancy test on Study Day 1 for female subjects of child-bearing potential.

Exclusion Criteria

Known hypersensitivity to Pinatos 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 per mm3 or a history of thrombocytopenia.-Confirmed diagnosis of chronic liver disease.-Positive for HIV.-Female subjects who are pregnant or nursing mothers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of AV411 at a single dose level in healthy subjects[Daily]

Secondary Outcome Measures

Name	Time	Method
Plasma collection for pharmacokinetic sampling[On Study days 2, 3, 5, 10, 13, 17 and 20];Full pharmacokinetic analysis[On Study days 1, 6 and 16.];Urine collection for metabolite analyses[On Study days 1, 6, 16 and 20.]