NCT00522808

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2007

Geographic Reach
2 countries

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

7 months

First QC Date

August 29, 2007

Last Update Submit

September 26, 2008

Conditions

Chronic Hepatitis C

Keywords

HCVantiviralPKSafety

Outcome Measures

Primary Outcomes (4)

  • Safety

  • PK

  • Tolerability

  • Antiviral activity

Interventions

A-831DRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • Voulnteers with concurrent medical conditions or taking concurrent medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

ACS

Auckland, New Zealand

Location

Birmingham WTCRF

Birmingham, B15 2TH, United Kingdom

Location

DDS

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Sanderson

    DDS

    PRINCIPAL INVESTIGATOR

  • David Mutimer

    WTCRF Birmingham

    PRINCIPAL INVESTIGATOR

  • Edward Gane

    ACS New Zealand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 30, 2007

Study Start

August 1, 2007

Primary Completion

March 1, 2008

Study Completion

May 1, 2008

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

GB(2)NZ(1)