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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712280
Other study ID # MNK61062107
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 1, 2018
Est. completion date July 14, 2020

Study information

Verified date June 2021
Source Mallinckrodt
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date July 14, 2020
Est. primary completion date July 14, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Puerto Rico Fundacion de Investigacion (Research Foundation) San Juan
United States Southern California Research Center Coronado California
United States Inland Empire Clinical Trials Rialto California
United States Global Clinical Professionals Saint Petersburg Florida
United States American Research Corporation at the Texas Liver Institute San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ammonia Plasma Levels at Baseline and 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.
Baseline, Day 5
Secondary Number of Participants With Adverse Events by the End of the Trial End of trial is defined as 7 (+/-3) days after last study treatment within 15 days
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