A Study of the PK, Safety and Antiviral Activity of A-831... | NCT00522808

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

NCT00522808

Sponsor

Arrow Therapeutics

Status

Terminated

Last Update Posted

Sep 29, 2008Estimated

Enrollment

36Estimated

Phase

Phase 1Phase 2

Conditions

Chronic Hepatitis C

Interventions

A-831

Countries

New Zealand
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Need for re-formulation

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

Mar 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Aug 29, 2007

First Submission Date that Met QC Criteria

Aug 29, 2007

First Posted Date

Aug 30, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2008

Last Update Posted Date

Sep 29, 2008Estimated

Name	Class
DDS, Dundee	UNKNOWN
David Mutimer, Birmingham	UNKNOWN
Ed Gane, ACS New Zealand	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Estimated

Name	Type	Description	Arm Group Labels	Other Names
A-831	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Brian Sanderson	DDS	Principal Investigator
David Mutimer	WTCRF Birmingham	Principal Investigator
Edward Gane	ACS New Zealand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ACS		Auckland			New Zealand
Birmingham WTCRF

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Safety
PK
Tolerability
Antiviral activity