NCT06362460已完成1 期
Single-center, Open-label, Non-randomized and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 400mg [14C]RAY1216
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2023年9月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total radioactivity in plasma PK
研究概览
简要总结
This study is a single-center, open-label, and single-dose clinical study to evaluate the mass balance, biotransformation and pharmacokinetics of [14C]RAY1216 in healthy Chinese male participants, revealing the overall pharmacokinetic characteristics of RAY1216.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Males and female participants between 18-45 years (Both inclusive);
- •Body weight≥50kg.Body mass index (BMI) 18~28 kg/m2 (Both inclusive); BMI is determined by the following equation: BMI = weight/height2 (kg/m2);
- •Participants who voluntarily sign the informed consent form, understand the trial procedures, and be willing to comply with all trial procedures and restrictions.
排除标准
- •Any clinically significant abnormality upon physical examination or in the clinical laboratory tests. History or presence of a clinically significant gastrointestinal, renal, hepatic, neurologic, hematic, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular and cerebrovascular disorder(s) (but not limited to above disorders).
- •Presence of human immunodeficiency virus (HIV), viral hepatitis(including hepatitis C virus (HCV) or hepatitis B virus (HBV) ,treponema pallidum antibodies at screening.
- •Participants who donated blood or bleeding profusely(> 400 mL)in the 3 months preceding study screening.
- •Participants who have undergone surgery within 6 months before the screening period or whose surgical incision is not completely healed; Major surgery includes, but is not limited to, any surgery with a significant risk of bleeding, or an open biopsy or significant traumatic injury;
- •Workers engaged in conditions requiring long-term exposure to radioactivity; Or have significant radiation exposure (≥2 chest/abdomen CT, or ≥3 other types of X-ray examinations) within 1 year before this study or have participated in the radiopharmaceutical labeling test;
- •Participants who smoked an average of >5 cigarettes per day in the previous 3 months or habitually used nicotine-containing products and were unable to quit during the trial period;
- •Substance abuse or use of soft drugs (e.g., marijuana) in the 3 months prior to the screening period or use of hard drugs (e.g., cocaine, amphetamines, etc.) in the 1 year prior to the screening period; Or screening for positive urine drug abuse (drug) tests;
- •Participants who have special dietary requirements and cannot comply with a uniform diet;
- •History of allergic conditions or allergic diseases, or a history of allergic reactions attributed to RAY1216 or any of the ingredients of its formulation or similar drugs.
研究组 & 干预措施
[14C]RAY1216
Experimental
干预措施: [14C] RAY1216 (Drug)
结局指标
主要结局
Total radioactivity in plasma PK
时间窗: Up to 7 days from the start of administration.
Vz/F
Mass balance recovery of total radioactivity in all (urine, faeces) amount excreted (Ae) expressed as a percentage of the administered dose (%Ae)
时间窗: Up to 14 days from the start of administration.
次要结局
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0(Up to 14 days (approx) from the start of administration.)
研究者
研究点 (1)
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