A 2-Stage Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IW-1701 Tablets in Healthy Subjects in a Double-blind, Placebo-controlled, Multiple-ascending-dose Stage and an Open-label, Single-dose, Crossover Food-effect Stage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Treatment Emergent Adverse Event
研究概览
简要总结
The objectives of this study are:
Stage 1: To assess the safety, tolerability, pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of a range of doses of IW-1701 tablets administered orally to healthy subjects over 7 days of repeated dosing
Stage 2: To assess the safety, tolerability, PK profile and PD effects of IW-1701 tablets administered orally to healthy subjects, in fed and fasted states, in an open-label, single-dose, 2-period, 2-sequence crossover study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an ambulatory male or female between 18 and 55 years old at the screening visit
- •Subject's body mass index score is > 18.5 and < 30.0 kg/m2 at the screening visit
- •Women of childbearing potential must have a negative pregnancy test at the time of check-in and must agree to use double-barrier contraception throughout the duration of the study
- •Subject is in good health and has no clinically significant findings on a physical examination
- •Other inclusion criteria per protocol
排除标准
- •History of any clinically significant medical conditions
- •Other exclusion criteria per protocol
研究组 & 干预措施
IW-1701
IW-1701 tablets administered orally in multiple ascending dose.
干预措施: IW-1701 (Drug)
Placebo
Matching placebo tablets administered orally.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment Emergent Adverse Event
时间窗: 47 Days
Maximum observed plasma concentration [Cmax]
时间窗: 47 Days
Maximum observed Plasma Concentration
Area under the plasma concentration time curve during a dosing interval [AUC]
时间窗: 47 Days
Area under the plasma concentration time curve during a dosing interval
Time of maximum observed plasma concentration [Tmax]
时间窗: 47 Days
Time of maximum observed plasma concentration
Blood Pressure
时间窗: 47 Days
次要结局
未报告次要终点