NCT07559474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 Moderate or Severe Hepatic Impairment
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
- 4
- 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 moderate or severe hepatic impairment.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to comprehend and willingness to sign a written ICF for the study.
- •Aged 18 to 80 years, inclusive, at the time of signing the ICF.
- •Moderate or severe hepatic impairment based on CP score.
- •Medical findings consistent with the degree of hepatic dysfunction, determined by medical history, physical examination, vital sign measurements, 12-lead ECGs, and clinical laboratory determinations at screening or check-in (as applicable). Participants with abnormal findings considered not clinically significant by the medical monitor or investigator are eligible.
- •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.
- •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 2 months prior to check-in.
- •Participants who required new medication or an increase in dose for hepatic encephalopathy 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 have a portal systemic shunt. Up to 3 participants with transjugular intrahepatic portosystemic shunt may be included.
- •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
Cohort 1: Moderate hepatic function
Experimental
Participants with moderate hepatic impairment will be enrolled in Cohort 1.
干预措施: INCB123667 (Drug)
Cohort 2: Severe hepatic function
Experimental
Participants with severe hepatic impairment will be enrolled in Cohort 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 2 months
Defined as the maximum plasma concentration.
PK for plasma INCB123667: AUCt
时间窗: Up to approximately 2 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 2 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 2.5 months)
研究者
研究点 (4)
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