An Open-Label, Single-Center, 2-Part, Parallel Study to Determine the Absolute Bioavailability and the Absorption, Metabolism, and Elimination Properties of [14C]E7386 in Healthy Male Subjects

Eisai Limited1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2022年10月17日最近更新: 2023年9月21日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Eisai Limited
入组人数: 15
试验地点: 1
主要终点: Part 1, CL/F: Apparent Total Body Clearance of E7386

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

The primary purpose of this study is to evaluate the absolute bioavailability of E7386 following a single oral dose of E7386 as a one 40 milligram (mg) immediate release (IR) tablet and concomitant intravenous (IV) microdose of (14C)E7386 (100 mcg [microgram]) solution for Part 1 and to determine the pharmacokinetic (PK) and excretion of E7386 following a single 40 mg powder in capsule (PIC) oral administration of (14C)E7386 for Part 2.

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: 30 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Non-smoking, healthy male, age greater than or equal to (>=) 30 years and less than or equal to (<=) 55 years old at the time of informed consent
•Body Mass Index (BMI) of greater than (>) 18 to less than (<) 30 kilogram per square meter (kg/m^2) as measured at Screening
•Adequate organ function per blood work
•Participant must have regular bowel movements (that is, average stool production of >=1 and <=3 stools per day)
•Participant must agree to adhere to the contraception requirements

排除标准

•Have participated in any clinical research study involving nonradiolabeled investigational product within 90 days prior to Day -1 (Baseline) or involving radiolabeled investigational product within 12 months prior to Day -1 (Baseline)
•Participant has had exposure to significant diagnostic or therapeutic radiation (example, serial X-ray, computed tomography scan, barium meal) or current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1 (Baseline)
•Male participant with pregnant or breastfeeding partner
•Male participant who is unwilling to follow the contraception rules of the study for up to 92 days after last dose of the study drug
•Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks prior to dosing
•A prolonged QT/QTc interval (QTcF [corrected QT interval by Fridericia] >450 millisecond [ms]) as confirmed by a repeated ECG at Screening or Baseline, or a history of risk factors for torsade de pointes (example, heart failure, hypokalemia, family history of long QT Syndrome), or the use of concomitant medications that prolonged the QT/QTc interval
•Known history of clinically significant drug, food allergies, or presently experiencing any seasonal or perennial allergy at Screening and Baseline (Day -1)
•Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus (HIV) antibody at Screening
•History of recreational drug use, drug or alcohol dependency or abuse within the 2 years before Screening, or those who have a positive urine drug test or breath alcohol test at Screening or admission
•Participant who is, or is an immediate family member of, a study site or sponsor employee
•Participant does not have suitable veins for multiple venipunctures/cannulations as assessed by the investigator or delegate at Screening
•Receipt of blood products within 4 weeks prior to dosing, or donation of blood or plasma within the previous 3 months, or loss of greater than 400 mL of blood
•Any history of or concomitant medical condition that in the opinion of the investigator would compromise the participant's ability to safely complete the study at Screening and Day -1 (Baseline)
•Failure to satisfy the investigator of fitness to participate for any other reason

研究组 & 干预措施

Part 1: E7386 40 mg Tablet + (14C)E7386

Experimental

Participants will be administered a single oral dose of E7386 40 mg tablet on Day 1 followed by an intravenous infusion containing a microdose solution of [14C]E7386 (100 mcg) with not more than (NMT) 7.4 kilobecquerel (kBq) (0.20 microcurie [mcCi]), starting approximately 25 minutes post oral dose administered as 5 milliliter (mL) over 5 minutes to coincide with the time at which the highest drug concentration occurs (tmax) for E7386 after an oral dose.

干预措施: E7386 Tablet (Drug)

Part 1: E7386 40 mg Tablet + (14C)E7386

Experimental

干预措施: (14C)E7386 (Drug)

Part 2: (14C)E7386 40 mg Capsule

Experimental

Participants will be administered a single oral dose of E7386 40 mg capsule radiolabeled with approximately 2.96 megabecquerel (MBq) (80 mcCi) (14C)E7386 (final dose to depend on the specific activity of [14C]E7386) in the morning on Day 1 after an overnight fasting.

干预措施: (14C)E7386 Capsule (Drug)