A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers (CP104)

September 26, 2008 updated by: Arrow Therapeutics

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • ACS
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Birmingham WTCRF
      • Dundee, United Kingdom, DD1 9SY
        • DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety
Tolerability
PK
Antiviral activity

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arrow Therapeutics

Collaborators

DDS, Dundee
David Mutimer, Birmingham
Ed Gane, ACS New Zealand

Investigators

  • Principal Investigator: Brian Sanderson, DDS
  • Principal Investigator: David Mutimer, WTCRF Birmingham
  • Principal Investigator: Edward Gane, ACS New Zealand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

August 29, 2007

First Submitted That Met QC Criteria

August 29, 2007

First Posted (Estimate)

August 30, 2007

Study Record Updates

Last Update Posted (Estimate)

September 29, 2008

Last Update Submitted That Met QC Criteria

September 26, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP104

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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