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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00522808




Registration number
NCT00522808
Ethics application status
Date submitted
29/08/2007
Date registered
30/08/2007
Date last updated
29/09/2008

Titles & IDs
Public title
A Study of the PK, Safety and Antiviral Activity of A-831 in HCV Carriers
Scientific 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
Secondary ID [1] 0 0
CP104
Universal Trial Number (UTN)
Trial acronym
CP104
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - A-831

Treatment: Drugs: A-831


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety
Timepoint [1] 0 0
Primary outcome [2] 0 0
PK
Timepoint [2] 0 0
Primary outcome [3] 0 0
Tolerability
Timepoint [3] 0 0
Primary outcome [4] 0 0
Antiviral activity
Timepoint [4] 0 0

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
60 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Voulnteers with concurrent medical conditions or taking concurrent medications

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Birmingham
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Dundee

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arrow Therapeutics
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
DDS, Dundee
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
David Mutimer, Birmingham
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Ed Gane, ACS New Zealand
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT00522808
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Brian Sanderson
Address 0 0
DDS
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00522808