NCT05657834已完成1 期
A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
适应症
干预措施
相关药物
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
- [14C]TVB-2640: AUC-inf in plasma
研究概览
简要总结
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]TVB-2640 healthy male subjects.
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, of any race, between 19 and 55 years of age, inclusive.
- •In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee).
- •History of a minimum of 1 bowel movement per day
排除标准
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- •History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities.
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
- •Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
- •Use of any sensitive substrates of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to IMP administration (Day 1).
- •Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
研究组 & 干预措施
Treatment Arm 1
Experimental
Single dose of TVB-2640, 50 mg, oral administration
干预措施: [14C]-TVB-2640 (Drug)
结局指标
主要结局
[14C]TVB-2640: AUC-inf in plasma
时间窗: Up to 22 days
[14C]TVB-2640: Amount excreted in urine
时间窗: Up to 22 days
[14C]TVB-2640: Amount excreted in feces
时间窗: Up to 22 days
次要结局
未报告次要终点
研究者
研究点 (1)
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