Pharmacology study of AZD7295 in otherwise healthy HCV carriers.
Research type
Research Study
Full title
A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetic, 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
IRAS ID
8104
Contact name
Graham R Foster
Contact email
Sponsor organisation
Arrow Therapeutics Ltd
Eudract number
2008-004690-18
Clinicaltrials.gov Identifier
00781976
Research summary
It is estimated that approximately 170 million people worldwide are infected with chronic Hepatitis C virus (HCV) infection, which is a major cause of liver disease, including cirrhosis and cancer of the liver, and is recognised as the leading indication for liver transplant in the developed world. Current ??standard of care? combination pegylated interferon plus ribavirin has poor efficacy, particularly in genotype 1 HCV infection, in which only 50% of patients achieve a sustained viral response. Combination pegylated interferon plus ribavirin is also poorly tolerated, with dose reductions in more than 50% and treatment cessation in approximately 10% because of side-effects. More effective and better tolerated therapies are urgently needed. The investigational drug, AZD7295, is in a new class of anti-viral agents potentially active against HCV. It is being developed as an oral treatment for people with HCV, particularly those with genotype 1. The proposed study will assess the pharmacokinetics, safety and tolerability, and antiviral effect of AZD7295 in relatively well people infected with HCV. In this double-blind, multiple ascending dose study, up to four groups of 10 HCV carriers (40 participants in total) will be randomised to receive AZD7295 or placebo.
REC name
West of Scotland REC 1
REC reference
08/S0703/138
Date of REC Opinion
8 Oct 2008
REC opinion
Favourable Opinion