NCT03712280

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Cirrhosis
• Hepatic Encephalopathy (HE)

Interventions

Type	Name	Description
DRUG	MNK6106	1 gram tablet of MNK6106 for oral administration
DRUG	Rifaximin	550 mg tablet of rifaximin for oral administration

Timeline

• Start date: 2018-12-01
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2018-10-19
• Last updated: 2021-07-20
• Results posted: 2021-07-20

Locations

5 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study