A Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of LOXO-783 in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
研究概览
简要总结
The main purpose of this study is to measure how much of LOXO-783 is in the bloodstream and how the body handles and eliminates LOXO-783 when administered in fasting and fed states in healthy participants. The study will also evaluate the safety and tolerability of LOXO-783. Participation could last up to 63 days including screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Healthy status as defined by the absence of evidence of any clinically significant active or chronic disease
- •Body mass index (BMI): 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
排除标准
- •Females who are lactating or of childbearing potential
- •Clinically significant history of any drug sensitivity, drug allergy, or food allergy
研究组 & 干预措施
LOXO-783 (Fasted State)
LOXO-783 administered orally to participants who are in fasted state
干预措施: LOXO-783 (Drug)
LOXO-783 (Fed State - Low Fat Meal)
LOXO-783 administered orally to participants who are on low fat meal
干预措施: LOXO-783 (Drug)
LOXO-783 (Fed State - High Fat Meal)
LOXO-783 administered orally to participants who are on high fat meal
干预措施: LOXO-783 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LOXO-783
时间窗: Predose on Day 1 up to 96 hours postdose
PK: Cmax of LOXO-783
PK: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC [0-∞]) of LOXO-783
时间窗: Predose on Day 1 up to 96 hours postdose
PK: AUC \[0-∞\] of LOXO-783
次要结局
未报告次要终点