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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-07-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Cirrhosis Hepatic Encephalopathy (HE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A: MNK6106 2 grams (tid)

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

Group Type EXPERIMENTAL

MNK6106

Intervention Type DRUG

1 gram tablet of MNK6106 for oral administration

Group B: MNK6106 4 grams (bid)

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

Group Type EXPERIMENTAL

MNK6106

Intervention Type DRUG

1 gram tablet of MNK6106 for oral administration

Group C: MNK6106 4 grams (tid)

Participants receive 4 tablets of MNK6106 tid for 5 days

Group Type EXPERIMENTAL

MNK6106

Intervention Type DRUG

1 gram tablet of MNK6106 for oral administration

Group D: Rifaximin 550 mg (bid)

Participants receive 1 tablet of rifaximin bid for 5 days

Group Type ACTIVE_COMPARATOR

Rifaximin

Intervention Type DRUG

550 mg tablet of rifaximin for oral administration

Interventions

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MNK6106

1 gram tablet of MNK6106 for oral administration

Intervention Type DRUG

Rifaximin

550 mg tablet of rifaximin for oral administration

Intervention Type DRUG

Other Intervention Names

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Study Drug L-Ornithine Phenylacetate Xifaxan

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No