A Phase 1 Open-Label, Randomized, Crossover Study to Evaluate the Bioavailability, Effect of Food, Palatability, and Safety of Various DNL343 Oral Formulations in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
研究概览
简要总结
This is a Phase 1 relative bioavailability study carried out in approximately 24 healthy male subjects and healthy female subjects of non childbearing potential to investigate the effects of formulation and food on the safety, tolerability, and pharmacokinetics (PK) of DNL343.
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) ≥18.5 to < 30 kg/m2 and body weight of at least 50 kg
- •For women: Must have been surgically sterilized or be postmenopausal.
排除标准
- •History of clinically significant endocrine, pulmonary, cardiovascular, gastrointestinal, hepatic, pancreatic, renal, metabolic, hematologic, immunologic, or allergic disease, or other major disorders
- •History of malignancy, except fully resected basal cell carcinoma
- •History of clinically significant neurologic or psychiatric diseases; head trauma with loss of consciousness; or clinically significant depression or suicidal ideation
研究组 & 干预措施
Cohort A
干预措施: DNL343 (Drug)
Cohort A
干预措施: Placebo (Drug)
Cohort B
干预措施: DNL343 (Drug)
Cohort B
干预措施: Placebo (Drug)
Cohort C
干预措施: DNL343 (Drug)
结局指标
主要结局
PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma
时间窗: Up to 15 days
PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma
时间窗: Up to 15 days
PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma
时间窗: Up to 15 days
PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
时间窗: Up to 15 days
次要结局
- PK parameter: Maximum observed concentration (Cmax) of DNL343 in plasma in the fed versus fasted states(Up to 15 days)
- PK parameter: Time to maximum observed concentration (Tmax) of DNL343 in plasma in the fed versus fasted states(Up to 15 days)
- PK Parameter: Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-t) of DNL343 in plasma in the fed versus fasted states(Up to 15 days)
- PK parameter: The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma in the fed versus fasted states(Up to 15 days)
- Incidence of treatment-emergent adverse events (TEAEs)(Up to 15 days)