NCT04859244已完成1 期
First-in-Human Evaluation of the Safety, Tolerability, and Pharmacokinetics of Orally Administered GS-441524 in a Healthy Human Volunteer
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
- 1
- 试验地点
- 1
- 主要终点
- Emergence of treatment-related adverse events (AEs)
研究概览
简要总结
This is a two-part study is to evaluate the multi-day safety, tolerability, and pharmacokinetics (PK) of orally administered GS-441524 in a healthy human volunteer.
详细描述
Part 1: 750 mg GS-441524 administered once daily (QD) for 7 days. Part 2: 750 mg GS-441524 administered three times daily (TID) for 3 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Willing and able to provide written informed consent
- •Negative pregnancy test at screening and prior to dosing
- •Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
排除标准
- •Use of other investigational drugs within 28 days of dosing
- •Positive pregnancy test
- •Abuse of alcohol or drugs
- •Other clinically significant medical conditions or laboratory abnormalities
研究组 & 干预措施
Part 1: GS-441524 (QD, 7 days)
Experimental
750 mg GS-441524 administered QD for 7 days
干预措施: GS-441524 (Drug)
Part 2: GS-441524 (TID, 3 days)
Experimental
750 mg GS-441524 administered TID for 3 days
干预措施: GS-441524 (Drug)
结局指标
主要结局
Emergence of treatment-related adverse events (AEs)
时间窗: Day 7
Treatment-related AEs are defined as significant changes to blood chemistry (CBC, CMP) or 6-lead ECG.
次要结局
- Pharmacokinetic (PK) Parameter: AUC0-24h of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: AUClast of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: T1/2 of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: Cmax of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: Tmax of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: Clast of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: Tlast of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
- PK Parameter: AUCtau of GS-441524 in Parts 1 and 2.(Intensive PK: Day 1 to Day 7)
研究者
研究点 (1)
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