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

Overview

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.

Full Title of Study: “A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 14, 2020

Interventions

  • Drug: MNK6106
    • 1 gram tablet of MNK6106 for oral administration
  • Drug: Rifaximin
    • 550 mg tablet of rifaximin for oral administration

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Ammonia Plasma Levels at Baseline and Day 5
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mallinckrodt
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Team Leader, Study Director, Mallinckrodt

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