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NCT00522808 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

— CP104  

Official title:
A Clinical Pharmacology Study to Determine the Pharmacokinetic , Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of A-831 in Otherwise Healthy Male Hepatitis C Carriers With Compensated Liver Disease

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00522808
Other study ID # CP104
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received August 29, 2007
Last updated September 26, 2008
Start date August 2007
Est. completion date May 2008

Study information
Verified date September 2008
Source Arrow Therapeutics
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Terminated
Enrollment 36
Est. completion date May 2008
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 60 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• A-831

Locations
Country Name City State
New Zealand ACS Auckland
United Kingdom Birmingham WTCRF Birmingham
United Kingdom DDS Dundee

Sponsors (4)
Lead Sponsor Collaborator
Arrow Therapeutics David Mutimer, Birmingham, DDS, Dundee, Ed Gane, ACS New Zealand

Countries where clinical trial is conducted

New Zealand,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety
Primary PK
Primary Tolerability
Primary Antiviral activity
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