The main reason for this study is to see how the study drug interacts with the body.

It will compare different doses of the study drug with a drug already in use.

Participants will be adults with liver disease that has affected the brain in the past.

Key Inclusion Criteria:

A potential participant may only be included if (at screening), he/she:

1. Understands the study and has signed informed consent
2. Is an adult, not pregnant or lactating
3. Has cirrhosis of the liver
4. Has had 1 instance of HE within 12 months
5. Has hyperammonaemia defined as ≥37 μmol/L at screening

Key Exclusion Criteria:

A potential participant will be excluded if (at screening), he/she:

1. Has contraindicated allergies

2. Expects liver transplant within 1 month

3. Has had a liver shunt within the last 3 months

4. Has inadequate kidney, gastrointestinal, or cardiac function

5. Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:

   1. the safety and well-being of the participant or potential offspring
   2. the safety of study staff
   3. the analysis of results

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03712280) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.