A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers

Phase 1

Terminated

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00522808
• Lead Sponsor: Arrow Therapeutics

Brief Summary

The purposes of this study are:

* to determine the safety and tolerability of multiple doses of A-831 at various doses

* to determine how multiple doses of A-831 are distributed through the bloodstream

* to determine if A-831 reduces the amount of Hepatitis C virus in the blood

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-08-29
• Study First Submitted QC: 2007-08-29
• Study First Posted: 2007-08-30
• Primary Completion: 2008-03
• Study Completion: 2008-05
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-26
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• Volunteers will be males of any race aged 18-60 years with a BMI between 18 and 32 kg/m2 at the time of the screening medical
• Volunteers who have given their written informed consent to participate in the study
• Volunteers who are willing and able to comply with the protocol and study procedures
• Volunteers who have a diagnosis of chronic hepatitis C infection and are in good health (other than history of Hepatitis C infection)

Exclusion Criteria

• Voulnteers with concurrent medical conditions or taking concurrent medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Safety
Antiviral activity
PK
Tolerability

Trial Locations

Locations (3)

ACS; 🇳🇿 Auckland, New Zealand

Birmingham WTCRF; 🇬🇧 Birmingham, United Kingdom

DDS; 🇬🇧 Dundee, United Kingdom