A Phase 1 Study to Evaluate the Pharmacokinetics and Safety of Multiple Doses of Cedirogant (ABBV-157) in Subjects With Mild, Moderate and Severe Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)
研究概览
简要总结
The objective of this study is to evaluate the pharmacokinetics and safety of cedirogant following oral administration of multiple doses in adult participants with hepatic impairment and normal hepatic function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Body Mass Index (BMI) is ≥ 18.0 to < 40 kg/m2
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile (except liver function tests for subjects with hepatic impairment), and 12-lead ECG
排除标准
- •Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests (except liver function tests for subjects with hepatic impairment) at screening that is assessed as likely to interfere with the objectives of the trial or the safety of the subject.
- •History or evidence of active TB or latent TB infection
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of cervix
研究组 & 干预措施
Group 2: Cedirogant
Participants will receive cedirogant once daily.
干预措施: Cedirogant (Drug)
Group 3: Cedirogant
Participants will receive cedirogant once daily.
干预措施: Cedirogant (Drug)
Group 4: Cedirogant
Participants will receive cedirogant once daily.
干预措施: Cedirogant (Drug)
Group 1: Cedirogant
Participants will receive cedirogant once daily.
干预措施: Cedirogant (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve (AUC) from time 0 to 24 hours after dosing (AUC0-24)
时间窗: Up to 18 Days
AUC from time 0 to 24 hours after dosing
Time to maximum observed plasma concentration (Tmax)
时间窗: Up to 18 Days
Time to maximum observed plasma concentration
Maximum Observed Plasma Concentration (Cmax)
时间窗: Up to 18 Days
Maximum Observed Plasma Concentration
次要结局
- Number of Participants with Adverse Events(Up to 44 Days)