NCT07751250招募中1 期
A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of Casdatifan (AB521) in Participants With Moderate Hepatic Impairment Compared to Healthy Matched Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
研究概览
简要总结
The purpose of the study is to compare the single dose PK of casdatifan between participants with moderate hepatic impairment (HI) and healthy matched control participants 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
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •Male participants must be vasectomized
- •BMI ≥ 18.0 and ≤ 42.0 kg/m2 and body weight ≥ 45 kg at screening.
- •Participants with Moderate HI (Group 1)
- •Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) at screening.
- •Has a diagnosis of chronic (> 6 months), stable (no acute episodes of illness within the previous 2 months due to deterioration in hepatic function) hepatic insufficiency at screening
- •Healthy Participants:
- •Healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and ECGs, as deemed by the PI or designee
排除标准
- •All Participants:
- •Participants with Gilbert's syndrome.
- •Participants with Moderate HI (Group 1):
- •Positive for HBsAg or HCV Ab, and detectable viral load at screening.
- •Severe complications of liver disease within the preceding 3 months of screening.
- •Fluctuating or rapidly deteriorating hepatic function from screening until prior to dosing, in the opinion of the PI or designee.
- •Healthy Control Participants:
- •History or presence of clinically significant medical or psychiatric condition or disease, or presence of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Group 2: Healthy Control Participants
Experimental
Administered as specified in the treatment arm.
干预措施: Casdatifan (Drug)
Group 1: Moderate Hepatic Impairment
Experimental
Administered as specified in the treatment arm.
干预措施: Casdatifan (Drug)
结局指标
主要结局
Area under the concentration time curve, from time 0 to the last observed non-zero concentration, of casdatifan in plasma (AUC0-t)
时间窗: Up to 10 days post-dose
Area under the concentration time curve from time 0 extrapolated to infinity of casdatifan in plasma (AUC0-inf)
时间窗: Up to 10 days post-dose
Maximum observed concentration of casdatifan in plasma (Cmax)
时间窗: Up to 10 days post-dose
次要结局
- Time to reach Cmax of casdatifan in plasma (Tmax)(Up to 10 days post-dose)
- Apparent first order terminal elimination rate constant calculated from a semi log plot of the plasma concentration versus time curve (Kel)(Up to 10 days post-dose)
- Percent of AUC0-inf extrapolated (AUC%extrap)(Up to 10 days post-dose)
- Apparent first order terminal elimination half life (t½)(Up to 10 days post-dose)
- Apparent total clearance (CL/F)(Up to 10 days post-dose)
- Apparent total clearance (Vz/F)(Up to 10 days post-dose)
- Unbound fraction (fu) of casdatifan(Up to 10 days post-dose)
- Number of participants experiencing Adverse Events (AEs)(Up to 23 days post-dose)
研究者
研究点 (1)
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