A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- PK Parameter: AUC0-∞
研究概览
简要总结
This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males, aged between 18 to 65 years, inclusive
- •Body mass index between 18.0 and 32.0 kg/m2
- •In good health
- •When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
- •History of a minimum of 1 bowel movement per day
排除标准
- •History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
- •Have a history of malignancy, except fully resected basal cell carcinoma
- •History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
- •History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
- •Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343
研究组 & 干预措施
14C-DNL343
干预措施: [14C]-DNL343 (Drug)
结局指标
主要结局
PK Parameter: AUC0-∞
时间窗: 28 days
The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of DNL343 in plasma
Total radioactivity in blood-to-plasma ratio
时间窗: 28 days
PK Parameter: Cmax
时间窗: 28 days
Maximum observed concentration (Cmax) of DNL343 in plasma
PK Parameter: t1/2
时间窗: 28 days
Terminal elimination half-life (t1/2) of DNL343 in plasma
Total radioactivity in plasma and whole blood
时间窗: 28 days
Extent and rate of recovery of total radioactivity in urine and feces
时间窗: 28 days
PK Parameter: AUC0-tlast
时间窗: 28 days
Area under the concentration-time curve from time zero to the last quantifiable time point (AUC0-tlast) of DNL343 in plasma
PK Parameter: Tmax
时间窗: 28 days
Time to maximum observed concentration (Tmax) of DNL343 in plasma
次要结局
- PK Parameter: AUC0-∞(28 days)
- PK Parameter: Cmax(28 days)
- DNL343 and a DNL343 metabolite recoveries in urine(28 days)
- PK Parameter: t1/2(28 days)
- PK Parameter: Tmax(28 days)
- PK Parameter: AUC0-tlast(28 days)
- Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)(28 days)