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

M

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:

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

Key Exclusion Criteria:

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

  • Has contraindicated allergies
  • Expects liver transplant within 1 month
  • Has had a liver shunt within the last 3 months
  • Has inadequate kidney, gastrointestinal, or cardiac function

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

  • the safety and well-being of the participant or potential offspring
  • the safety of study staff
  • the analysis of results

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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