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

This study has been terminated.
(Need for re-formulation)
Sponsor:
Collaborators:
DDS, Dundee
David Mutimer, Birmingham
Ed Gane, ACS New Zealand
Information provided by:
Arrow Therapeutics
ClinicalTrials.gov Identifier:
NCT00522808
First received: August 29, 2007
Last updated: September 26, 2008
Last verified: September 2008
  Purpose

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 Intervention Phase
Chronic Hepatitis C
Drug: A-831
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:
  • Safety
  • PK
  • Tolerability
  • Antiviral activity

Estimated Enrollment: 36
Study Start Date: August 2007
Study Completion Date: May 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Julie Dent, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT00522808     History of Changes
Other Study ID Numbers: CP104
Study First Received: August 29, 2007
Last Updated: September 26, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Arrow Therapeutics:
HCV
antiviral
PK
Safety

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014