ACTRN12615001355561已完成1 期
Dose Ranging, Single Dose Safety and Pharmacokinetic Study of DUR-928 in Subjects with Nonalcoholic Steatohepatitis (NASH) and Control Healthy Subjects
INC Research0 个研究点目标入组 32 人开始时间: 2015年12月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •All participants:
- •* Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
- •* Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed;
- •* Female subjects must be of non-childbearing potential;
- •* Willing and be able to be admitted to the clinical study unit for 2 nights and 3 days;
- •* Able to abstain from alcohol and tobacco use during the trial.
- •NASH Subjects (in addition to All Participants”)
- •* A diagnosis of NASH on the basis of liver biopsy performed within the last 6 months or radiological evidence of steatosis and a clinical diagnosis of NASH based on fulfilling the remaining inclusion/exclusion criteria.
- •* For subjects with cirrhosis there must be a prior histological evidence of cirrhosis or clinical and/or radiological evidence of cirrhosis in conjunction with a FibroScan greater than or equal to 12.5 kPa and Child Pugh A 5-6.
- •* For non cirrhosis subjects there must be prior histological evidence for the absence of cirrhosis within the past 12 months or the absence of clinical and/or radiological evidence for cirrhosis in conjunction with a FibroScan less than 9.5 kPa.
- •For cirrhotic/non-cirrhotic indeterminate subjects will include subjects who have:
- •(a) Fibroscan greater than or equal to 12.5 but no radiological evidence of cirrhosis
- •(b) Fibroscan less than 12.5 but greater than or equal 9.5
- •(c) Clinical / radiological features of cirrhosis but Fibroscan less than 9.5
- •Healthy Volunteers (in addition to All Participants”)
- •* Subjects must have normal hepatic function.
- •* Demographically comparable to NASH subjects as follows:
- •^ Mean BMI (kg/m2) within +/- 25%
- •^ Mean age within +/- 10 years
- •^ Similar gender ratio
排除标准
- •All participants:
- •* Disease or surgery of the gastrointestinal tract that may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product
- •* Participation in an investigational drug study within 30 days prior to dosing.
- •* History of drug or alcohol abuse.
- •* Disease or surgery of the gastrointestinal tract that may interfere with drug absorption or may otherwise influence the pharmacokinetics of the investigational medicinal product (e.g., inflammatory bowel disease, restrictions of the small or large intestine, etc.)
- •* History of febrile illness within 5 days prior to dosing.
- •* Positive tests for HIV, hepatitis B, drugs of abuse or alcohol breath-test.
- •* Clinically significant abnormalities
- •* Women of child-bearing potential, pregnant or nursing (lactating) women
- •NASH Subjects (in addition to All Participants”)
- •* Subject has evidence of other forms of chronic liver disease
- •* Hepatic Cirrhosis with a Child-Pugh classification of B or C (score > 6)
- •* Alcohol use greater than or equal to 30 g/day
- •* Type I diabetes
- •* History of bariatric surgery
- •* Concurrent Anti-NASH therapy(s) with washout less than or equal to 30 days
- •* Viral hepatitis (i.e., serologies for Hepatitis B and C should be negative) However, subjects who are Hepatitis C Virus (HCV)-antibody positive but hepatitis C virus-ribonucleic acid (HCV-RNA) negative who have been successfully treated with antiviral agents and have a sustained virological response (SVR) following HCV therapy or documentation of HCV-RNA negative for a minimum of 6 months prior to inclusion and who meet all other eligibility criteria may be considered for enrollment.
- •Healthy Volunteers (in addition to All Participants”)
- •* Evidence of clinically significant uncontrolled hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, renal, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing)
- •* Presence of impaired renal function as indicated by abnormal creatinine (creatinine clearance < 80 ml/min) values and/or serum creatinine greater than or equal to 1.8 mg/dL
- •* History of regular alcohol consumption exceeding 28 drinks/week within 6 months of screening
- •* Positive tests for hepatitis C.
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