Antiviral Activity of AZD7295 in HCV Carriers

This study is not yet open for participant recruitment.

Verified by Arrow Therapeutics, October 2008

First Received: October 28, 2008 No Changes Posted

Sponsored by:	Arrow Therapeutics
Information provided by:	Arrow Therapeutics
ClinicalTrials.gov Identifier:	NCT00781976

Purpose

PK, safety study of AZD7295 in HCV carriers

Condition	Intervention	Phase
Hepatitis C	Drug: AZD7295 Drug: Placebo	Phase I

MedlinePlus related topics: Hepatitis Hepatitis C Liver Diseases

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacokinetics Study
Official Title:	A Randomised, DB, PC Study to Determine the PK, Safety and Tolerability Profile and Antiviral Activity of Multiple Oral Doses of AZD7295 in Otherwise Healthy Male and Female Hepatitis C Carriers With Compensated Liver Disease

Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:

Plasma AZD7295 concentrations and pharmacokinetics [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo
2: Active Comparator	Drug: AZD7295 700mg per day maximum

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781976

Contacts

Contact: Julie C Dent, PhD

442071051065

Sponsors and Collaborators

Arrow Therapeutics

Investigators

Principal Investigator:

Ed Gane

Auckland Clinical Services

More Information

No publications provided

Responsible Party:	Arrow Therapeutics ( Dr Julie Dent )
Study ID Numbers:	HCV689-102
Study First Received:	October 28, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00781976 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; New Zealand: Medsafe; Spain: regulatory authority

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Hepatitis, Viral, Human
Healthy
Hepatitis C
Antiviral Agents

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
Anti-Infective Agents
RNA Virus Infections
Liver Diseases
Digestive System Diseases

Flaviviridae Infections
Therapeutic Uses
Hepatitis, Viral, Human
Hepatitis C
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009