A Phase 1, Open-label, Single-dose Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics of a Single Oral Dose of ESK-001
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Alumis Inc
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
研究概览
简要总结
This a phase 1, open label, single dose, parallel cohort study to determine the pharmacokinetics (PK) of study drug (ESK-001) in healthy volunteer participants, and participants with mild, moderate, and severe renal impairment.
详细描述
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Severe Renal Impairment
8 participants with severe Renal impairment will receive a single dose of ESK-001
干预措施: ESK-001 (Drug)
Moderate Renal Impairment
8 participants with moderate renal impairment will receive a single dose of ESK-001
干预措施: ESK-001 (Drug)
Mild Renal Impairment
8 participants with mild renal impairment will receive a single dose of ESK-001
干预措施: ESK-001 (Drug)
Healthy Volunteer
Up to 24 healthy volunteer participants will receive a single dose of ESK-001
干预措施: ESK-001 (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: 48 hours
Maximum observed plasma concentration (Cmax)
时间窗: 48 hours
Incidence of nonserious adverse events (AE), serious adverse events (SAE), and AE leading to discontinuation
时间窗: 48 hours
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
时间窗: 48 hours
次要结局
- Number of clinically significant changes in clinical laboratory values, vital signs, ECGs, and physical examinations(48 hours)