QCL-1350 (HCV689-105)

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers

• IRAS ID

  47806

• Contact name

  Joanne Collier

• Sponsor organisation

  Arrow Therapeutics Ltd

• Eudract number

  2010-018272-24

• Research summary

  Chronic Hepatitis C virus (HCV) infection is a global public health problem and a major cause of liver disease, e.g. cirrhosis. Sufferers of HCV and in particular those infected with genotype 1, are currently offered treatment that is inefficient for 50% of patients and has significant side effects. The increasing occurrence of chronic HCV diagnosis means more effective therapies are needed. AZD7295 is a potent inhibitor of HCV with a novel mechanism of action, as evidenced in numerous pre-clinical experiments. There have been three completed Phase I clinical studies to date, and there is an ongoing Phase II study dosing HCV patients. Only one of the Phase I studies administered the IMP in a capsule form, while the other three have given AZD7295 orally in a liquid form. The primary purpose of this study is to evaluate the drug absorption profile and safety of and tolerance to an improved capsule formulation of AZD7295 which has been devised for this Phase I study. There will be up to three randomised subject groups of 6. The flexibility that is written-in to the protocol means that decisions regarding dose escalation will be made as the study progresses. A secondary, exploratory objective of the study is to take blood samples (with specific informed consent) for Pharmacogenetic testing which will allow DNA to be extracted for future retrospective analysis on how genetics affects the efficiency of HCV treatments.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/2

• Date of REC Opinion

  22 Mar 2010

• REC opinion

  Further Information Favourable Opinion