A Phase 1 Open-Label Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects with Primary Biliary Cholangitis with Compensated Cirrhosis and without Cirrhosis (A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis. )
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16
- 主要终点
- PK parameters after a single dose of K-808
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-randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participant has a PBC diagnosis as demonstrated by the presence of >=2 of the following three diagnostic criteria:
- •History of ALP above ULN for at least 6 months
- •History of positive antimitochondrial antibody (AMA) titer or positive PBC-specific antinuclear antibody (ANA) titers
- •Historical liver biopsy consistent with PBC
- •Has PBC with cirrhosis Child-Pugh grade A (well-compensated disease; score 5 to 6) at Screening. Group 2 (PBC w/ CIRR CP-A) only
- •Male or female participant is >=18 years of age at consent.
- •Meet all other Inclusion criteria outlined in the clinical study protocol.
排除标准
- •Female subject of childbearing potential who is known to be pregnant, has a positive pregnancy test (serum test, or urine test that is confirmed by a positive serum pregnancy test), or is lactating and breastfeeding, or planning to become pregnant or breastfeed during the study.
- •Subject has had ongoing conditions that may affect drug absorption such as gastroparesis, intestinal obstruction, severe gastritis, severe gastric
- •reflux syndrome, conditions causing frequent vomiting and/or diarrhea.
- •Subject who has participated in another investigational drug, biologic, or medical device study within five half-lives of the agent (or within 8 weeks when half-life is unknown) prior to the first dose of study drug, or prior participation in an investigational antibody drug study within 6 months prior to the first dose of study drug. Participation in noninterventional studies (eg, observational studies, registries) is allowed.
- •Meet any other exclusion criteria outlined in the clinical study protocol.
结局指标
主要结局
PK parameters after a single dose of K-808
To evaluate the pharmacokinetics (PK) of K-808 in subjects with primary biliary cholangitis (PBC) without liver cirrhosis (hereinafter known as PBC w/o CIRR) and in subjects with PBC and compensated cirrhosis Child-Pugh grade A (hereinafter known as PBC w/ CIRR CP-A)
Trough concentrations after multiple dosing of K-808
To evaluate the pharmacokinetics (PK) of K-808 in subjects with primary biliary cholangitis (PBC) without liver cirrhosis (hereinafter known as PBC w/o CIRR) and in subjects with PBC and compensated cirrhosis Child-Pugh grade A (hereinafter known as PBC w/ CIRR CP-A)
PK parameters at steady state after multiple dosing of K-808
To evaluate the pharmacokinetics (PK) of K-808 in subjects with primary biliary cholangitis (PBC) without liver cirrhosis (hereinafter known as PBC w/o CIRR) and in subjects with PBC and compensated cirrhosis Child-Pugh grade A (hereinafter known as PBC w/ CIRR CP-A)
次要结局
未报告次要终点