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

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

Status
Terminated
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00522808
Acronym
CP104
Enrollment
36
Registered
2007-08-30
Start date
2007-08-31
Completion date
2008-05-31
Last updated
2008-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

HCV, antiviral, PK, Safety

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

Interventions

DRUGA-831

Sponsors

DDS, Dundee
CollaboratorUNKNOWN
David Mutimer, Birmingham
CollaboratorUNKNOWN
Ed Gane, ACS New Zealand
CollaboratorUNKNOWN
Arrow Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety
PK
Tolerability
Antiviral activity

Countries

New Zealand, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026