An Open-Label, Single-Dose Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine
研究概览
简要总结
The primary objective of this study is to determine the pharmacokinetics (PK) and excretion of E7090 and its metabolites in healthy male participants. Also, to assess the safety and tolerability of a single dose of E7090 in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Non-smoking, healthy males, age greater than or equal to (>=) 35 years and less than or equal to (<=) 55 years old at the time of informed consent
- •Body Mass Index (BMI) of >=18 to <=32 kilogram per square meter (kg/m^2) at Screening
- •Provide written informed consent
- •Willing and able to comply with all aspects of the protocol
- •History of a minimum of 1 bowel movement per day
排除标准
- •Participant has participated in any clinical research study involving a radiolabeled investigational product within the 12 months prior to Day -1 (Baseline)
- •Participant has previously completed or withdrawn from this study or any other study investigating E7090 or previously received E7090
- •Participant has had exposure to significant diagnostic or therapeutic radiation (example: serial x-ray, computed tomography scan, barium meal) or has current employment in a job requiring radiation exposure monitoring within 12 months prior to Day -1
- •Participant has the following ocular disorders:
- •Any previous history or current evidence of corneal disorder
- •Any previous history or current evidence of active macular disorder (example: age-related macular degeneration, central serous chorioretinal disease)
- •Participants has a known history of clinically significant drug allergy at Screening or Baseline (Day -1)
- •Participants has a known history of food allergies or significant seasonal or perennial allergy
- •Participants is known to be human immunodeficiency virus positive at Screening
- •Participants has active viral hepatitis (B or C) as demonstrated by positive serology at Screening
- •Participant has a poor peripheral venous access, in the opinion of the investigator (or designee)
- •Participant received blood products within 2 months prior to Day -1, or donation of blood within 3 months prior to Screening, donation of plasma within 2 weeks prior to Screening, or donation of platelets from 6 weeks prior to Screening
研究组 & 干预措施
E7090
Participants will receive 100 microcurie (μCi) of [14C]E7090 as a single 35 milligram (mg), capsule, orally on Day 1.
干预措施: [14C]E7090 (Drug)
结局指标
主要结局
feu: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine
时间窗: Up to Day 57
feu+ef: Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces)
时间窗: Up to Day 57
Cumulative feu: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Urine From 0 to tlast Hours
时间窗: Up to Day 57
Cumulative fef: Cumulative Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces From 0 to tlast Hours
时间窗: Up to Day 57
AUC(0-t): Area Under the Concentration- time Curve From Time 0 to Time of Last Quantifiable Concentration for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-672 hours post-dose
fef: Percentage of Administered Radioactive Dose of [14C]E7090 Excreted in Feces
时间窗: Up to Day 57
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-672 hours post-dose
T1/2: Terminal Elimination Phase Half-life for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-672 hours post-dose
CL/F: Apparent Total Body Clearance for E7090
时间窗: Day 1: 0-672 hours post-dose
Vd/F: Apparent Volume of Distribution for E7090
时间窗: Day 1: 0-672 hours post-dose
MPR AUC(0-inf): Metabolite to Parent Ratio For AUC(0-inf) of Metabolite to E7090, Corrected for Molecular Weights
时间窗: Day 1: 0-672 hours post-dose
Cumulative feu+ef: Cumulative Percentage of Administered Radioactive Dose excreted of [14C]E7090 in Combined Excreta (Urine and Feces) From 0 to tlast Hours
时间窗: Up to Day 57
Cmax: Maximum Observed Plasma Concentration for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-672 hours post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-672 hours post-dose
AUC(0-24h): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for [14C]E7090, E7090 and its Metabolites
时间窗: Day 1: 0-24 hours post-dose
次要结局
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters Values(Baseline up to Day 29)
- Metabolic profile of E7090: Concentration of Metabolite of E7090 in Plasma, Urine, and Feces(Up to Day 57)
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)(Baseline up to Day 57)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values(Baseline up to Day 29)
- Number of Participants With Clinically Significant Change From Baseline in 12 Lead Electrocardiogram (ECG) Findings(Baseline up to Day 29)
- Number of Participants With Any Suicidality Assessed Using Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline up to Day 29)
- Number of Participants With Clinically Significant Change From Baseline in Ophthalmic Examinations(Baseline up to Day 29)
- Number of Participants With Clinically Significant Change From Baseline in Physical Examinations(Baseline up to Day 29)