A Phase 1, Open-Label, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Duvelisib in Subjects With Chronic Hepatic Impairment Compared to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
研究概览
简要总结
To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.
详细描述
This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of nonchildbearing potential between 18-70 years of age
- •Body Mass Index (BMI): 18.0 - 38.0 kg/m
- •Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- •Hepatic impairment subjects: confirmed hepatic impairment >1 year with etiology of chronic alcoholism, chronic viral hepatitis (B or C), nonalcoholic steatohepatitis, autoimmune hepatitis, Wilson disease, alpha-1 antitrypsin deficiency, glycogen storage diseases, or galactosemia
- •Provided written informed consent prior to any study specific procedures
排除标准
- •Women of childbearing potential
- •Hepatic impairment subjects: fluctuating or rapidly deteriorating hepatic function, acute hepatitis, variceal bleeding within 8 weeks of screening, a history of pancreatitis within 8 weeks of screening, evidence of hepatic encephalopathy > Grade 1, current unstable hematologic condition, and/or creatinine clearance < 60 mL/min
- •Healthy subjects: positive screening test for hepatitis B surface antigen, or hepatitis C antibody
- •ECG at screening or Day -1 showing QTcF ≥ 450 msec for healthy subjects or > 500 msec for hepatically impaired subjects
- •Evidence of clinically significant medical conditions
- •History of gastrointestinal disease or surgery that may affect drug absorption
- •Positive or indeterminate QuantiFERON-TB Gold test at screening
- •Any active infection at the time of screening or admission
研究组 & 干预措施
Moderate Hepatic Impairment
干预措施: IPI-145 (Drug)
Mild Hepatic Impairment
干预措施: IPI-145 (Drug)
Healthy Subjects
干预措施: IPI-145 (Drug)
Severe Hepatic Impairment
Optional arm based on results from Arms 1, 2, and 3
干预措施: IPI-145 (Drug)
结局指标
主要结局
Pharmacokinetic parameters of IPI-145 and its primary metabolite, IPI-656
时间窗: Open 72 hours
PK parameters (AUC, Cmax and t1/2) of IPI-145 and its metabolite, IPI-656 Plasma concentrations of IPI-145 and its metabolite, IPI-656
次要结局
- Incidence of adverse events following administration of IPI-145(10 days)