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

Mallinckrodt

Status and phase: Completed; Phase 2

Conditions: Hepatic Cirrhosis; Hepatic Encephalopathy (HE)

Treatments: Drug: Rifaximin; Drug: MNK6106

Study type: Interventional

Funder types: Industry

Identifiers

NCT03712280

MNK61062107

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 4 patient groups

Group A: MNK6106 2 grams (tid)

Experimental group

Description:

Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days

Treatment:

Drug: MNK6106

Group B: MNK6106 4 grams (bid)

Experimental group

Description:

Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days

Treatment:

Drug: MNK6106

Group C: MNK6106 4 grams (tid)

Experimental group

Description:

Participants receive 4 tablets of MNK6106 tid for 5 days

Treatment:

Drug: MNK6106

Group D: Rifaximin 550 mg (bid)

Active Comparator group

Description:

Participants receive 1 tablet of rifaximin bid for 5 days

Treatment:

Drug: Rifaximin