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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Ammonia Plasma Levels at Baseline and Day 5
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A potential participant may only be included if (at screening), he/she:
- •Understands the study and has signed informed consent
- •Is an adult, not pregnant or lactating
- •Has cirrhosis of the liver
- •Has had 1 instance of HE within 12 months
- •Has hyperammonaemia defined as ≥37 μmol/L at screening
排除标准
- •A potential participant will be excluded if (at screening), he/she:
- •Has contraindicated allergies
- •Expects liver transplant within 1 month
- •Has had a liver shunt within the last 3 months
- •Has inadequate kidney, gastrointestinal, or cardiac function
- •Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:
- •the safety and well-being of the participant or potential offspring
- •the safety of study staff
- •the analysis of results
研究组 & 干预措施
Group A: MNK6106 2 grams (tid)
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
干预措施: MNK6106 (Drug)
Group B: MNK6106 4 grams (bid)
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
干预措施: MNK6106 (Drug)
Group C: MNK6106 4 grams (tid)
Participants receive 4 tablets of MNK6106 tid for 5 days
干预措施: MNK6106 (Drug)
Group D: Rifaximin 550 mg (bid)
Participants receive 1 tablet of rifaximin bid for 5 days
干预措施: Rifaximin (Drug)
结局指标
主要结局
Ammonia Plasma Levels at Baseline and Day 5
时间窗: 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.
次要结局
- Number of Participants With Adverse Events by the End of the Trial(within 15 days)