A Phase 1, Open Label, Non-Randomized Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Oral Seladelpar in Subjects With Varying Degrees of Hepatic Impairment and Healthy Matched Control Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Area under of the curve (AUC0-t and AUC0-∞)
研究概览
简要总结
This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 是
入选标准
- •Must have given written informed consent (signed and dated) and any authorizations required by local law.
- •Willing to be confined to CRU for the entire duration required by the protocol.
- •Male or female, between 18 and 80 years of age.
- •Healthy subject with normal liver function must be non-smoker and no use of other tobacco or nicotine-containing products. Subject with HI must be non-smoker, or smoke ≤10 cigarettes per day during the study.
- •Healthy subject must not be taking any prescribed or non-prescribed medications unless permitted. Subject with HI will be allowed to take their chronic medications unless excluded by the protocol.
排除标准
- •Pregnant or lactating women.
- •Treatment with another investigational drug or device within 30 days prior to study drug administration.
- •Has donated or lost a significant volume of blood within 56 days or plasma within 7 days prior to Check-in day.
- •Inability to swallow medication.
- •Positive test for drugs of abuse and/or positive alcohol test at Screening or Day -
- •Positive test at Screening for HBsAg, hepatitis C virus (HCV), or HIV.
研究组 & 干预措施
Normal
Child-Pugh Score: N/A
Subjects will receive a single 10 mg oral dose of seladelpar
干预措施: seladelpar (Drug)
Mild Impairment
Child-Pugh Score: A (5 to 6 points)
Subjects will receive a single 10 mg oral dose of seladelpar
干预措施: seladelpar (Drug)
Moderate Impairment
Child-Pugh Score: B (7 to 9 points)
Subjects will receive a single 10 mg oral dose of seladelpar
干预措施: seladelpar (Drug)
Severe Impairment
Child-Pugh Score: C (10 to 15 points)
Subjects will receive a single 10 mg oral dose of seladelpar
干预措施: seladelpar (Drug)
结局指标
主要结局
Area under of the curve (AUC0-t and AUC0-∞)
时间窗: 5 days
Elimination of half-life (t1/2)
时间窗: 5 days
Total body clearance (CL/F)
时间窗: 5 days
Time to reach maximum concentration (Tmax)
时间窗: 5 days
Apparent terminal elimination rate constant (λz)
时间窗: 5 days
Volume of distribution (Vz/F)
时间窗: 5 days
Maximum plasma concentration (Cmax)
时间窗: 5 days
次要结局
未报告次要终点