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

Phase 2

Completed

• Conditions: Hepatic Cirrhosis; Hepatic Encephalopathy (HE)
• Interventions: Drug: MNK6106; Drug: Rifaximin

• Registration Number: NCT03712280
• Lead Sponsor: Mallinckrodt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-16
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Study Start: 2018-12-01
• Primary Completion: 2020-07-14
• Study Completion: 2020-07-14
• Status Verified: 2021-06
• Results First Submitted: 2021-06-29
• Results First Submitted QC: 2021-06-29
• Last Update Submitted: 2021-06-29
• Results First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: MNK6106 2 grams (tid)	MNK6106	Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Group B: MNK6106 4 grams (bid)	MNK6106	Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Group C: MNK6106 4 grams (tid)	MNK6106	Participants receive 4 tablets of MNK6106 tid for 5 days
Group D: Rifaximin 550 mg (bid)	Rifaximin	Participants receive 1 tablet of rifaximin bid for 5 days

Primary Outcome Measures

Name	Time	Method
Ammonia Plasma Levels at Baseline and Day 5	Baseline, Day 5	This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine.; If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events by the End of the Trial	within 15 days	End of trial is defined as 7 (+/-3) days after last study treatment

Trial Locations

Locations (5)

Global Clinical Professionals; 🇺🇸 Saint Petersburg, Florida, United States

Inland Empire Clinical Trials; 🇺🇸 Rialto, California, United States

Southern California Research Center; 🇺🇸 Coronado, California, United States

American Research Corporation at the Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Fundacion de Investigacion (Research Foundation); 🇵🇷 San Juan, Puerto Rico