A Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- PK for plasma of INCB000928: AUC0-∞
研究概览
简要总结
This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 82 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
Group 1: Normal Renal Function
Participants with normal levels of renal function will receive a single oral dose of INCB000928 200 mg on Day 1.
干预措施: INCB000928 (Drug)
Group 2: Mild Renal Impairment
Participants with mild levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
干预措施: INCB000928 (Drug)
Group 3: Moderate Renal Impairment
Participants with moderate levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
干预措施: INCB000928 (Drug)
Group 4: Severe Renal Impairment
Participants with severe levels of renal impairment will receive a single oral dose of INCB000928 200 mg on Day 1.
干预措施: INCB000928 (Drug)
Group 5: Kidney Failure
Group 5 participants with ESRD maintained on HD will receive a single dose of INCB000928 on Day 1 of each of 2 treatment periods before (Period 1) and after (Period 2) an HD session in order to study the effects of HD on INCB000928.
干预措施: INCB000928 (Drug)
结局指标
主要结局
PK for plasma of INCB000928: AUC0-∞
时间窗: Days 1 - 4
Defined as area under the single-dose plasma or serum concentration-time curve extrapolated to time of infinity, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
PK for plasma of INCB000928: Cmax
时间窗: Days 1 - 4
Defined as maximum observed plasma or serum concentration, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928
PK for plasma of INCB000928: AUC0-t
时间窗: Days 1 - 4
Defined as area under the steady-state plasma or serum concentration-time curve over 1 dose interval, this test will assess the effect of renal impairment and hemodialysis on the exposure of single oral doses of INCB00928.
次要结局
- PK for plasma of INCB000928: AUC3-7(Days 1 - 4)
- Number of treatment-related adverse events(Days 1-4 and follow up; up to 14 days)
- PK for plasma of INCB000928: tmax(Days 1 - 4)
- PK for plasma of INCB000928: t½(Days 1 - 4)
- PK for plasma of INCB000928: CL/F(Days 1 - 4)
- PK for plasma of INCB000928: Vz/F(Days 1 - 4)