NCT06962332招募中1 期
A Phase 1, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Zanzalintinib in Participants With Moderate Hepatic Impairment
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- Exelixis
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib
研究概览
简要总结
The primary purpose of this study is to evaluate the plasma PK of zanzalintinib following a single dose in participants with moderate liver dysfunction compared to matched healthy participants with normal liver 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Participants:
- •No clinically significant medical history (aside from the HI for participants in the HI group only), physical examination findings, or vital signs, as deemed by the investigator.
- •A continuous non-smoker or moderate smoker who smokes ≤ 10 cigarettes, ≤ 2 cigars, or ≤2 pipes per day and agree to limit smoking during the confinement period to ≤ 4 cigarettes or ≤1 cigar or pipe per day. Participant must agree to maintain the same smoking status (smoker or non-smoker) from screening and until after the last PK sample collection.
- •Has not donated blood within 30 days of dosing or plasma within 7 days of dosing and must agree to refrain from blood donation until at least 30 days following dosing.
- •Participants with Moderate HI Only:
- •Adequate bone marrow function, at the screening and dosing visit.
- •Is classified as having moderate HI by the Child-Pugh classification system (Class B, score of 7 to 9, inclusive) and has a total bilirubin value within the range of > 1.5* upper limit of normal (ULN) and ≤ 3* ULN at the screening and dosing visit.
- •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 the screening visit with features of cirrhosis due to any etiology.
- •Healthy Control Participants Only:
- •Age must be within ± 10 years of the mean age of participants with moderate HI. The sex ratio (male/female ratio), and smoking status ratio (smokers/non-smokers ratio) must be the same to the sex and smoking status ratio of participants with moderate HI.
排除标准
- •All Participants:
- •• History of any medical or surgical conditions that would potentially alter absorption, distribution, metabolism, and/or excretion of orally administered drugs.
- •Has or is at risk for major cardiac events or dysfunction.
- •Participants with Moderate HI Only:
- •History of liver or other solid organ transplant.
- •Fluctuating or rapidly deteriorating hepatic function (the definition of the change of more than 1 Child-Pugh point) within 30 days prior to Day 1, in the opinion of the investigator and Sponsor.
- •Symptoms or history of Grade 3 or worse degree of encephalopathy within 3 months of dosing.
- •Clinical evidence of severe ascites at the screening visit or at check in.
- •Healthy Control Participants Only:
- •History or presence of alcohol or drug abuse within the past 2 years prior to dosing.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Moderate HI
Experimental
Participants with moderate HI will receive a single oral dose of zanzalintinib tablet on Day 1.
干预措施: Zanzalintinib (Drug)
Matched Healthy Control
Active Comparator
Matched healthy control participants will receive a single oral dose of zanzalintinib tablet on Day 1.
干预措施: Zanzalintinib (Drug)
结局指标
主要结局
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Time t Corresponding to the Last Quantifiable Concentration (AUC0-t) of Zanzalintinib
时间窗: Predose up to 7 days postdose
Maximum Observed Plasma Drug Concentration (Cmax) of Zanzalintinib
时间窗: Predose up to 7 days postdose
Time to Cmax (Tmax) of Zanzalintinib
时间窗: Predose up to 7 days postdose
次要结局
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)(Up to 30 days)
研究者
研究点 (2)
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