A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 主要终点
- Assessment of bioequivalence of the IPI-145 test and reference formulations
研究概览
简要总结
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
详细描述
This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts.
Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days.
Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women of non-child bearing potential between 18-50 years of age
- •Body Mass Index (BMI): 18.0 - 32.0 kg/m
- •Healthy subjects: in good health, determined by no clinically significant findings from clinical evaluations
- •Provided written informed consent prior to any study specific procedures
排除标准
- •Women of childbearing potential
- •Healthy subjects: positive screening test for hepatitis B surface antigen, hepatitis C antibody, or HIV-1/HIV-2 antibodies
- •ECG at screening showing QTcF ≥ 450 msec
- •Evidence of clinically significant medical conditions
- •History of gastrointestinal disease or surgery that may affect drug absorption
- •Positive T-Spot (tuberculosis)TB test at screening
- •Any active infection at the time of screening or admission
研究组 & 干预措施
Part 1 Cohort 1
IPI-145 test formulation (capsule) high single dose and IPI-145 reference formulation (capsule) high single dose
干预措施: IPI-145 (duvelisib) (Drug)
Part 1 Cohort 2
IPI-145 test formulation (capsule) low single dose and IPI-145 reference formulation (capsule) low single dose
干预措施: IPI-145 (Drug)
Part 2 Cohort 3
IPI-145 test formulation (capsule) high single dose administered under fasted and fed conditions
干预措施: IPI-145 (Drug)
结局指标
主要结局
Assessment of bioequivalence of the IPI-145 test and reference formulations
时间窗: 24 Hours
Pharmacokinetic Parameter (Cmax) of IPI-145
时间窗: Over 24 hours
Pharmacokinetic Parameter (AUClast ) of IPI-145
时间窗: Over 24 hours
Pharmacokinetic Parameter (AUCinf ) of IPI-145
时间窗: Over 24 hours
次要结局
- Incidence of adverse events following administration of IPI-145(7 weeks)