NCT02022306已完成1 期
A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects
Theravance Biopharma1 个研究点 分布在 1 个国家目标入组 111 人开始时间: 2014年2月最近更新:
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
- 111
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level >40 IU/L
- •Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.
排除标准
- •Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.
- •Subject has an estimated creatinine clearance of <90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.
- •Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).
研究组 & 干预措施
SAD TD-6450
Placebo Comparator
Single ascending dose (Part A)
干预措施: Placebo (Drug)
MAD TD-6450
Placebo Comparator
Multiple ascending dose (Part B)
干预措施: Placebo (Drug)
SAD TD-6450
Placebo Comparator
Single ascending dose (Part A)
干预措施: TD-6450 (Drug)
MAD TD-6450
Placebo Comparator
Multiple ascending dose (Part B)
干预措施: TD-6450 (Drug)
Food effect of TD-6450
Active Comparator
Food effect will be assessed in Part A (SAD) of this study.
干预措施: TD-6450 (Drug)
结局指标
主要结局
Adverse events
时间窗: 28 days max
次要结局
- Cmax(28 days max)
- T1/2(28 days max)
- Tmax(28 days max)
- Food effect on AUC value(15 days max)
- AUC(28 days max)
研究者
研究点 (1)
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