Back to resultsA Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers (CP104)
Primary Purpose
Chronic Hepatitis C
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
A-831
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring HCV, antiviral, PK, Safety
Eligibility 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
Sites / Locations
- ACS
- Birmingham WTCRF
- DDS
Outcomes
Primary Outcome Measures
Safety
PK
Tolerability
Antiviral activity
Secondary Outcome Measures
Full Information
NCT ID
NCT00522808
First Posted
August 29, 2007
Last Updated
September 26, 2008
Sponsor
Arrow Therapeutics
Collaborators
DDS, Dundee, David Mutimer, Birmingham, Ed Gane, ACS New Zealand
1. Study Identification
Unique Protocol Identification Number
NCT00522808
Brief Title
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Terminated
Why Stopped
Need for re-formulation
Study Start Date
August 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arrow Therapeutics
Collaborators
DDS, Dundee, David Mutimer, Birmingham, Ed Gane, ACS New Zealand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
HCV, antiviral, PK, Safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
A-831
Primary Outcome Measure Information:
Title
Safety
Title
PK
Title
Tolerability
Title
Antiviral activity
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Sanderson
Organizational Affiliation
DDS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Mutimer
Organizational Affiliation
WTCRF Birmingham
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Edward Gane
Organizational Affiliation
ACS New Zealand
Official's Role
Principal Investigator
Facility Information:
Facility Name
ACS
City
Auckland
Country
New Zealand
Facility Name
Birmingham WTCRF
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
DDS
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers
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