Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in ACLF

• Research type

  Research Study

• Full title

  A Placebo-Controlled, Multicenter, Double-Blind, Randomized, Pharmacokinetic and Pharmacodynamic Trial of IDN-6556 in Subjects with Acute-on-Chronic Liver Failure

• IRAS ID

  131676

• Contact name

  Stephen Ryder

• Contact email

  Stephen.Ryder@nuh.nhs.uk

• Sponsor organisation

  Conatus Pharmaceuticals Inc.

• Eudract number

  2012-004245-33

• Research summary

  The main purpose of the study is to examine the pharmacokinetics (blood levels over time) and pharmacodynamics (how the drug is working in the body)of IDN-6556 (also known as emricasan and PF-03491390) in subjects with acute-on-chronic liver failure (ACLF). Additionally, the study will look at whether IDN-6556 will reduce or stop the progression of liver damage and overall survival of subjects with ACLF.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  13/NW/0464

• Date of REC Opinion

  19 Aug 2013

• REC opinion

  Further Information Favourable Opinion