Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14

Exclusion Criteria

• •1. Evidence of severe decompensation
• •2. Severe hepatic impairment defined as a Child-Pugh score ≥10
• •3. ALT \>3 times upper limit of normal (ULN) or AST \>5 times ULN during screening
• •4. Estimated creatinine clearance \<30 mL/min
• •5. Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
• •6. Known portal vein thrombosis
• •7. Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy, other definitive treatment (e.g. sphincterotomy), or medical management (e.g. ursodeoxycholic acid)
• •8. Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters
• •9. Alpha-fetoprotein \>50 ng/mL
• •10. History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of \>500 msec
• •11. History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
• •12. Prior liver transplant
• •13. Change in diabetes medications or vitamin E within 3 months of screening
• •14. Uncontrolled diabetes mellitus (HbA1c \>9%) within 3 months of screening
• •15. Significant systemic or major illness other than liver disease
• •16. HIV infection
• •17. Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
• •18. If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
• •19. Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1