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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00522808
Recruitment Status : Terminated (Need for re-formulation)
First Posted : August 30, 2007
Last Update Posted : September 29, 2008
Sponsor:
Collaborators:
DDS, Dundee
David Mutimer, Birmingham
Ed Gane, ACS New Zealand
Information provided by:
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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: A-831 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : August 2007
Primary Completion Date : March 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Safety
  2. PK
  3. Tolerability
  4. Antiviral activity


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00522808


Locations
New Zealand
ACS
Auckland, New Zealand
United Kingdom
Birmingham WTCRF
Birmingham, United Kingdom, B15 2TH
DDS
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Arrow Therapeutics
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

Responsible Party: Julie Dent, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT00522808     History of Changes
Other Study ID Numbers: CP104
First Posted: August 30, 2007    Key Record Dates
Last Update Posted: September 29, 2008
Last Verified: September 2008

Keywords provided by Arrow Therapeutics:
HCV
antiviral
PK
Safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents