NCT07455084尚未招募1 期
A Phase 1 Trial to Assess the Mass Balance and Pharmacokinetics of a Single Oral Administration of 14C-SEP-380135 in Healthy Male Adults
Otsuka Pharmaceutical Development & Commercialization, Inc.1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2026年3月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Total Radioactivity Amount Excreted in Urine (Ae,u)
研究概览
简要总结
The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) between 18.0 and 32.0 kilograms per square meter (kg/m²).
- •In good overall health, based on:
- •Medical history
- •Physical examination
- •Neurological examination
- •Vital signs
- •Electrocardiogram (ECG)
- •Blood and urine tests (serum chemistry, hematology, urinalysis, serology)
- •Regular daily bowel movements (at least one per day) for 30 days before Day -
- •Ability to provide written informed consent and follow all study instructions.
- •Has a stable living situation at screening and agrees to return to a similar living arrangement after the in-clinic stay.
排除标准
- •Have taken an investigational drug within 30 days or 5 half-lives, if known, (whichever is longer) prior to screening.
- •Have had prior exposure to SEP-
- •Are currently participating in another clinical trial.
- •Attempted suicide within 12 months prior to screening.
- •A history of sick sinus syndrome, any degree of atrioventricular block, Heart attack (myocardial infarction), heart failure (NYHA Class II-IV), cardiomyopathy, pulmonary congestion, cardiac arrhythmias, prolonged QT interval, congenital long QT syndrome, family history of long QT, or moderate to severe hypokalemia. A participant with non-clinically significant ECG abnormalities at screening and check-in requires approval from the medical monitor and the sponsor's physician.
- •Are predicted poor metabolizer CYP2D6 phenotypes. Note: Other protocol-specified inclusion/exclusion criteria may apply.
研究组 & 干预措施
14C-SEP-380135
Experimental
Participants receive a single oral administration of 14C-SEP-380135 on Day 1.
干预措施: 14C-SEP-380135 (Drug)
结局指标
主要结局
Total Radioactivity Amount Excreted in Urine (Ae,u)
时间窗: Up to Day 8
Total Radioactivity Amount Excreted in Feces (Ae,f)
时间窗: Up to Day 8
Fraction of Dose Excreted in Urine (%fe,u)
时间窗: Up to Day 8
Fraction of Dose Excreted in Feces (%fe,f)
时间窗: Up to Day 8
次要结局
- Time for Cmax (tmax) of SEP-380135 and Metabolites(Up to Day 8)
- Apparent Clearance of Drug From Plasma After Oral Administration (CL/F) of SEP-380135(Up to Day 8)
- Area Under the Concentration-Time Curve From Time Zero to the Last Observable Concentration at Time (AUCt) of SEP-380135 and Metabolites(Up to Day 8)
- Area Under the Concentration-Time Curve From Time Zero to Infinity (AUC∞) of SEP-380135 and Metabolites(Up to Day 8)
- Elimination Half-Life (t1/2,z) of SEP-380135 and Metabolites(Up to Day 8)
- Volume of Distribution Following Oral Administration (Vz/F) of SEP-380135(Up to Day 8)
- Maximum Plasma Concentration (Cmax) of SEP-380135 and Metabolites(Up to Day 8)
- Apparent Clearance of Drug From Plasma After Oral Administration Adjusted for Body Weight (CL/F/BW) of SEP-380135(Up to Day 8)
- Number of Participants with Adverse Events (AEs)(Up to Day 31)
- Number of Participants with Potentially Clinically Significant Changes in Vital Signs(Upto Day 8)
- Number of Participants With Potentially Clinically Significant Changes in Electrocardiogram (ECG) Parameters(Upto Day 8)
- Number of Participants With Potentially Clinically Significant Changes in Physical Examinations(Upto Day 8)
- Number of Participants With Potentially Clinically Significant Changes in Clinical Laboratory Test Parameters(Upto Day 8)
- Number of Participants With Incidence of Suicidal Ideation and Suicidal Behavior Using the Columbia-Suicide Severity Rating Scale (C-SSRS)(Upto Day 8)
研究者
研究点 (1)
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