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

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ClinicalTrials.gov Identifier: NCT03712280
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hepatic Cirrhosis Hepatic Encephalopathy (HE) Drug: MNK6106 Drug: Rifaximin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019


Arm Intervention/treatment
Experimental: Group A: MNK6106 2 grams (tid)
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Drug: MNK6106
1 gram tablet of MNK6106 for oral administration
Other Name: Study Drug

Experimental: Group B: MNK6106 4 grams (bid)
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Drug: MNK6106
1 gram tablet of MNK6106 for oral administration
Other Name: Study Drug

Experimental: Group C: MNK6106 4 grams (tid)
Participants receive 4 tablets of MNK6106 tid for 5 days
Drug: MNK6106
1 gram tablet of MNK6106 for oral administration
Other Name: Study Drug

Active Comparator: Group D: Rifaximin 550 mg (bid)
Participants receive 1 tablet of rifaximin bid for 5 days
Drug: Rifaximin
550 mg tablet of rifaximin for oral administration
Other Name: Xifaxan




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve (AUC0-24) for ammonia [ Time Frame: within 24 hours post-dose ]

Secondary Outcome Measures :
  1. Number of participants with adverse events by the end of the trial [ Time Frame: within 10 days ]
  2. Maximum plasma concentration (Cmax) of phenylacetic acid [ Time Frame: within 5 days ]
  3. Number of participants with symptoms of high levels of ammonia in the blood (hyperammonemic crisis) [ Time Frame: within 5 days ]
  4. Mean phenylacetylglutamine (PAGN) excreted in urine within 24 hours post-dose [ Time Frame: within 24 hours post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 2 instances of HE within 12 months (1 within the last 6)
  5. Has hyperammonaemia 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712280


Contacts
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Contact: For questions about participating 800-556-3314 clinicaltrials@mnk.com

Locations
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United States, California
Anaheim Clinical Trials, LLC Recruiting
Anaheim, California, United States, 92801
Southern California Research Center Recruiting
Coronado, California, United States, 92118
United States, Florida
Global Clinical Professionals Recruiting
Saint Petersburg, Florida, United States, 33702
United States, Texas
American Research Corporation at the Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Puerto Rico
Fundacion de Investigacion (Research Foundation) Recruiting
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Leader Mallinckrodt

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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT03712280     History of Changes
Other Study ID Numbers: MNK61062107
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Brain Diseases
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Liver Cirrhosis
Hepatic Encephalopathy
Fibrosis
Pathologic Processes
Liver Failure
Hepatic Insufficiency
Rifaximin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents