A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Cumulative excretion rate of total radioactivity in urine and feces
研究概览
简要总结
This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 participants.
After each participant receives a single intravenous infusion of 19 mg (approximately 50 μCi) of [¹⁴C] Purinostat Mesylate for Injection on the first day of the trial, whole blood, plasma, urine and feces samples will be collected at specified time points/time periods during the trial. By measuring the total radioactivity, the whole blood-to-plasma ratio of total radioactivity, the pharmacokinetic parameters of total, recovery rate and excretion route data of the total radioactivity in whole blood (if applicable) and plasma.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •- All participants must:1.Chinese healthy adult male, aged 18-45 years old 2.Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2 3.Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
排除标准
- •- Participants must not：1.Those with allergic predisposition, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are severely allergic to the investigational product (IP)s and its excipients or HDAC inhibitors; 2.Those with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within one week before the screening period; 3.Those who have taken any clinical trial drugs or participated in any other clinical trials within 3 months before screening; 4.Be alcohol dependent or drug abusers.
研究组 & 干预措施
Purinostat Mesylate
干预措施: 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate (Drug)
结局指标
主要结局
Cumulative excretion rate of total radioactivity in urine and feces
时间窗: Through 216 hours postdose
次要结局
- Tmax(Through 120 hours postdose)
- AUC0-t(Through 120 hours postdose)
- t1/2(Through 120 hours postdose)
- Cmax(Through 120 hours postdose)