A Multicenter Phase 0 Study In Healthy Subjects and Subjects With Either Hepatic Or Renal Impairment To Obtain Plasma For Assessment In Vitro Lenvatinib Protein Binding

Eisai Inc.3 个研究点分布在 1 个国家目标入组 54 人开始时间: 2016年12月2日最近更新: 2018年9月7日

适应症

干预措施

试验速览

阶段: 早期 1 期
状态: 已完成
发起方: Eisai Inc.
入组人数: 54
试验地点: 3
主要终点: Number of participants with any serious adverse event and any non-serious adverse event

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. The primary objective of the study is to obtain plasma from participants for use in in vitro protein binding studies.

详细描述

E7080-A001-010 is a multicenter, parallel-group study in participants with mild, moderate, or severe hepatic or renal impairment and age-, gender-, and smoking status-matched healthy participants. Approximately 6 participants with each degree (mild, moderate, or severe) of hepatic or renal impairment will be enrolled. Two cohorts of 8 healthy participants will be enrolled. One cohort of healthy participants will be matched to the hepatic-impaired participants, whereas the other will be matched to the renal-impaired participants.

The study has 2 phases. The Pre-study Phase consists of a Screening Period and a Baseline Period. The Study Phase consists of a 2-day Study Period. No lenvatinib will be administered in this study.

The end of the study will be the date of the last study visit for the last participant in the study.

The following estimates are provided:

From first participant in to last participant out, the study is expected to take approximately one year to complete.
The maximum estimated duration of the study for each participant is anticipated to be approximately 5 weeks.

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 79 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Key Inclusion Criteria:
•Male or Female
•Age, at the time of Informed Consent:
•i. Hepatic Impairment Participants (Including Matched Healthy Participants): 18 to 70 years old, inclusive ii. Renal Impairment Participants (Including Matched Healthy Participants): 18 to 79 years old, inclusive
•Non-smokers and smokers who smoke no more than 10 cigarettes per day
•Besides diabetes and, as appropriate, renal or hepatic impairment, participants must have no history of acute or chronic clinically relevant disease or condition, as determined by the investigator.
•For participants with hepatic impairment:
•Liver cirrhosis that has been stable;
•Platelet count >30,000 cells/millimeter cubed (mm^3);
•Total score on the Child-Pugh classification system between 5 and 6 (Group 1, mild), 7 and 9 (Group 2, moderate), and 10 and 15 (Group 3, severe)
•For healthy participants:
•Creatinine clearance ≥ 81 milliliter per minute (mL/min)
•For participants with renal impairment:
•Must have a diagnosis of renal impairment that has been stable
•Must have renal impairment in the following categories based on creatinine clearance values: mild (creatinine clearance, 50 to 80 mL/min), moderate (creatinine clearance, 30 to 49 mL/min), or severe (creatinine clearance, 15 to 29 mL/min) renal impairment

排除标准

•Key Exclusion Criteria:
•Use of any new medication
•Human immunodeficiency virus (HIV) positive
•Presence of acute active liver disease or acute liver injury
•History of significant cardiovascular impairment
•Positive drug or alcohol test
•Weight loss or gain of >10% prior to Day 1
•Receipt of blood or blood products or donation of blood or blood products
•For participants with hepatic impairment:
•History of hepatic transplant, systemic lupus erythematosus, or hepatic coma
•Received treatment with interferon or pegylated interferon
•Participants who have encephalopathy >Grade 2, sepsis, or gastrointestinal bleeding; esophageal varices >Grade 2, acute hepatic failure of any etiology, history of surgical portosystemic shunt, renal impairment (creatinine clearance <50 mL/min according to the Cockcroft-Gault formula), and rapidly deteriorating hepatic function
•Systolic blood pressure (SBP) ≥ 160 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) ≥ 100 mmHg
•For healthy participants:
•Hemoglobin level less than 12.0 grams per deciliter (g/dL)
•For participants with renal impairment:
•A history of renal transplant
•SBP ≥ 160 mmHg and/or DBP ≥ 100 mmHg for participants with mild renal impairment; SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg for participants with moderate and severe renal impairment
•Significant bleeding diathesis