NCT07559396招募中1 期
A Phase 1, Open-Label Study to Assess the Safety and Pharmacokinetics of INCB123667 When Administered Orally to Adult Participants With Severe Renal Impairment or End Stage Renal Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- PK for plasma INCB123667: Cmax
研究概览
简要总结
This study will be conducted to assess the safety and pharmacokinetics of INCB123667 when administered orally to adult participants with severe renal impairment or end stage renal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 85 years, inclusive, at the time of signing the ICF.
- •Severe renal impairment or ESRD based on CKD-EPI.
- •Body mass index of 18.0 to 43.0 kg/m2 (inclusive).
- •Willingness to avoid pregnancy or fathering children.
排除标准
- •Participants who have a current, functioning organ transplant or are on the national transplant list and expected to receive a transplant within 3 months.
- •Participants with laboratory values outside the accepted range for participants with severe renal impairment or ESRD at screening. Participants with out-of-range values will be assessed by the investigator or designee for eligibility.
- •Tobacco or nicotine-containing product use of > 10 cigarettes per day within 1 month before screening.
- •Participants who had a change in disease status within 30 days before screening, as documented by the participant's medical history, that is deemed clinically significant by the investigator.
- •Participants who have a history of paracentesis within 3 months prior to check-in.
- •Participants who required new medication or an increase in dose for renal disease within 3 months prior to check-in.
- •Participants who have a history of unstable diabetes mellitus (as evidenced by hemoglobin A1c ≥ 10.0%). Medications for treatment of diabetes mellitus must be reviewed and approved by the investigator and medical monitor.
- •Participants who had esophageal banding within 3 months prior to check-in or required any other treatment for gastrointestinal bleeding within 6 months prior to check-in.
- •Other protocol-defined Inclusion/Exclusion Criteria may apply.
研究组 & 干预措施
Group 1: Severe Renal Impairment
Experimental
Participants with severe renal impairment will be enrolled in Group 1.
干预措施: INCB123667 (Drug)
Group 2: End Stage Renal Disease
Experimental
Participants with end stage renal disease will be enrolled in Group 2.
干预措施: INCB123667 (Drug)
结局指标
主要结局
PK for plasma INCB123667: Cmax
时间窗: Up to approximately 3 months
Defined as the maximum plasma concentration.
PK for plasma INCB123667: AUCt
时间窗: Up to approximately 3 months
Defined as area under the concentration-time curve from time zero to time of last quantifiable concentration.
PK for plasma INCB123667: AUC∞
时间窗: Up to approximately 3 months
Defined as area under the single-dose concentration-time curve extrapolated to time of infinity.
次要结局
- Number of Treatment-Emergent Adverse Events (TEAEs)(Up to approximately 3.5 months)
研究者
研究点 (2)
Loading locations...
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