MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)

• Status: Completed
• Trial end date: 2020-07-14
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Phenylacetic acid; Rifamycins; Rifaximin

Criteria

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