A Phase 1, Open-Label, Randomized, Crossover Study to Evaluate the Effect of a Low-Fat Meal and Evening Dosing on the Pharmacokinetics of KAI-7535 in Healthy Participants Living With Obesity or Overweight
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Time to Maximum Observed Concentration (Tmax) of KAI-7535
研究概览
简要总结
The primary objective of this study is to evaluate the effect of a meal and evening dosing on the pharmacokinetics (PK) of KAI 7535 in healthy participants living with obesity or overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥25.0 and ≤40.0 kg/m^
- •Medically healthy, as determined by prestudy medical history, and without clinically significant (CS) abnormalities.
排除标准
- •Known hypersensitivity to study treatment or any study treatment ingredients.
- •History or presence of CS cardiovascular, pulmonary, hepatic, renal, hematological, GI, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness, within the past 3 months.
- •Note: Additional inclusion/exclusion criteria may apply, per protocol.
研究组 & 干预措施
KAI-7535: Morning Dosing, Fed
Participants will receive KAI-7535 in the morning following a meal on dosing days.
干预措施: KAI-7535 (Drug)
KAI-7535: Morning Dosing, Fasted
Participants will receive KAI-7535 in the morning following an overnight fast on dosing days.
干预措施: KAI-7535 (Drug)
KAI-7535: Evening Dosing
Participants will receive KAI-7535 in the evening on dosing days.
干预措施: KAI-7535 (Drug)
结局指标
主要结局
Time to Maximum Observed Concentration (Tmax) of KAI-7535
时间窗: Pre-dose and up to 60 hours post-dose
Maximum Observed Concentration (Cmax) of KAI-7535
时间窗: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Time of Last Quantifiable Concentration (AUC0-t) of KAI-7535
时间窗: Pre-dose and up to 60 hours post-dose
Area Under the Concentration-time Curve From 0 to Infinity (AUC0-inf) of KAI-7535
时间窗: Pre-dose and up to 60 hours post-dose
次要结局
- Number of Participants with a Treatment-emergent Adverse Event (TEAE)(Day 1 up to Day 12)