A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Issthiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Health Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
研究概览
简要总结
This will be an open-label, non-randomized, absorption, metabolism, and excretion study of Lurasidone administered in a suspension at 40 mg to 6 normal healthy male subjects in a postprandial state
详细描述
A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [Isothiazolyl-3-14C]-Lurasidone Following Postprandial Single Oral Dose Administration in Healthy Male Subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •within a BMI range of 18.0 to 28.0 kg/m2 inclusive;
- •males will either be sterile or agree to use from Check-in until 45 days following Study Completion/Discharge approved methods of contraception
- •able to comprehend and willing to sign an Informed Consent Form (ICF);
- •able to void urine on a daily basis and 1 to 2 bowel movements per day.
- •able to swallow 60 mL of dosing suspension.
排除标准
- •history or presence of an abnormal ECG
- •participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in.
- •exposure to significant radiation within 12 months prior to Check-in;
- •participation in any other investigational study drug trial
- •use of any prescription medications/products within 14 days prior to Check-in
- •use of any inhibitors or inducers of CYP3A4 taken within 30 days prior to Check-in, including but not limited to drugs listed in Appendix E;
- •receipt of blood products within 2 months prior to Check-in;
研究组 & 干预措施
Lurasidone
LURASIDONE 40mg
干预措施: Lurasidone (Drug)
结局指标
主要结局
To determine the urinary and fecal recovery of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
时间窗: 28 days
To assess the pharmacokinetics (PK) of a postprandial single dose of 40 mg (150 Ci 5.55 Megabecquerels (MBq)) [Isothiazolyl-3-14C-Lurasidone and its metabolites
时间窗: 28 days
To determine the whole blood and serum concentrations of total radioactivity of [Isothiazolyl-3-14C]-Lurasidone (150 Ci).
时间窗: 28 days
次要结局
- To assess the safety of 40 mg [Isothiazolyl-3-14C]-Lurasidone(28 days)
- To determine serum concentrations of Lurasidone(28 days)
- To characterize and identify metabolites of Lurasidone in serum and urine(28 days)