A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of IW-6463 When Administered to Healthy Volunteers as Single Ascending Doses, as Multiple Ascending Doses, and Under Fed Versus Fasting Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
研究概览
简要总结
Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects
Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects
Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
- •Subject is in good health and has no clinically significant findings on physical examination
- •Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
- •Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
- •Other inclusion criteria per protocol
排除标准
- •Any active or unstable clinically significant medical condition
- •Use of any prescribed or non-prescribed medication
- •Other exclusion criteria per protocol
研究组 & 干预措施
IW-6463
IW-6463 tablets administered orally as single ascending doses, multiple ascending daily doses, and single doses with or without food
干预措施: IW-6463 (Drug)
Placebo
Matching placebo tablets administered orally
干预措施: Matching Placebo (Drug)
结局指标
主要结局
After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
时间窗: Up to 28 days
Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions
时间窗: Up to 21 days
After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
时间窗: Up to 9 days
After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
时间窗: Up to 32 days
次要结局
未报告次要终点