Pharmacokinetics of Lanabecestat (LY3314814) in Subjects With Impaired Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
研究概览
简要总结
The purpose of the study is to determine whether lanabecestat can be safely prescribed in participants with kidney impairment without a dose adjustment.
Participants will be on study for up to 6 weeks; this includes a 2-week screening and a follow-up about 10 days after final drug administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have a body mass index (BMI) of 19 to 40 kilograms per meter square (kg/m²)
排除标准
- •Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
- •Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
- •Have acute unstable neuropsychiatric disease
- •Have active or uncontrolled neurologic disease, or clinically significant head injury
研究组 & 干预措施
Lanabecestat Control
Lanabecestat administered orally to participants with normal renal function
干预措施: Lanabecestat (Drug)
Lanabecestat Severe Renal Impairment
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
干预措施: Lanabecestat (Drug)
Lanabecestat Severe Renal Impairment
Lanabecestat administered orally to participants with severe renal impairment, not on dialysis
干预措施: Iohexol (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Concentration Versus Time Curve From Zero To Infinity (AUC[0-∞]) for Lanabecestat
时间窗: Baseline through 168 hours after the administration of study drug
PK: AUC(0-∞) for Lanabecestat
PK: Maximum Observed Drug Concentration (Cmax) of Lanabecestat
时间窗: Baseline through 168 hours after the administration of study drug
PK: Cmax of Lanabecestat
次要结局
未报告次要终点