Evaluate Safety, Tolerability and Pharmacokinetics of Fadanafil （XZP-5849）in Chinese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Electrocardiogram (ECG)
研究概览
简要总结
The purpose of this study is to evaluate the safety , tolerability, and pharmacokinetics of ascending single dose Fadanafil （XZP-5849）in Chinese healthy adult male subjects. This is the first XZP-5849 clinical study
详细描述
XZP-5849 is a selective phosphodiesterase (PDE5) inhibitor. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single ascending dose study in approximately 66 Chinese healthy adult male subjects. The study consists of 8 cohorts (1 cohort per dose level). Each subject will participate in only one cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy male subjects 18-45 years old, inclusive.
- •Body weight ≥50kg and Body Mass Index: 19.0~25.0 kg/m2, inclusive
- •subjects should be willing to take appropriate contraceptive measures during the period of taking the study drug and within 6 months after discontinuation to avoid pregnancy of their partners.
排除标准
- •Subjects who have a history of clinical significanct drug allergy (especially those who are known or suspected to have a history of allergy to any PDE-5 inhibitor or its components) or a history of atopic allergic diseases (asthma, urticaria, eczema dermatitis) or severe allergic constitution.
- •History of clinically significant ECG abnormality or family history of long QT syndrome (grandparents, parents, brothers and sisters).
- •Subjects with serious systemic diseases, such as respiratory, blood, endocrine, cardiovascular and cerebrovascular diseases or mental disorders.
- •Subjects who have used over-the-counter drugs, health products, herbal medicine or traditional Chinese medicine within 2 weeks before screening, or are taking foods that affect CYP3A4, such as grapefruit or drinks containing grapefruit (except those who occasionally take paracetamol, but the total maximum dose cannot exceed 1g, and the drug is not allowed to take orally within 48 hours before the first administration).
- •Subjects who have used any prescription drugs (especially CYP3A4 inhibitors, nitrates, α receptor blockers, drugs potential to cause QT interval prolongation, etc.) within 4 weeks before screening.
研究组 & 干预措施
Fadanafil
8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose
干预措施: Fadanafil (Drug)
Placebo
8 group: 12.5mg one dose; 25mg one dose; 50mg one dose; 100mg one dose; 200mg one dose; 300mg one dose; 400mg one dose; 500mg one dose
干预措施: Placebo (Drug)
结局指标
主要结局
Electrocardiogram (ECG)
时间窗: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing.
To evaluate subject ECG Changing information
Pharmacokinetic Parameter AUC(0-24)
时间窗: Pre dose and 0.25,0.5,0.75,1,1.5, 2, 2.5, 4, 6,8,12, 24,36 hours after Dosing
AUC(0-24) of Fadanafile is area under the curve
Blood Pressure and Heart Rate
时间窗: Change from Baseline to 1, 2,4,6,8,12,24,36,46 hours after dosing
To evaluate subject Blood Pressure and Heart Rate Changing information
次要结局
未报告次要终点