A Phase 1, Open-Label, Multiple Dose Study to Evaluate the Pharmacokinetics of Entospletinib in Subjects With Normal and Impaired Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 6
- 主要终点
- Pharmacokinetic (PK) Parameter: AUCtau of ENTO
研究概览
简要总结
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate) relative to matched, healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Calculated body mass index from 18 to 40 kg/m^2
- •Not pregnant
- •Normal electrocardiogram
- •Participants with impaired liver function must be sufficiently healthy based upon medical history and physical examination, vital signs, and screening laboratory evaluations.
排除标准
- •Participation in another clinical study (current or within last 30 days)
- •HIV, hepatitis B virus, or active hepatitis C virus infection
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 1 (Moderate Hepatic Impairment)
Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.
干预措施: Entospletinib (Drug)
Cohort 2 (Severe Hepatic Impairment)
Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.
干预措施: Entospletinib (Drug)
Cohort 3 (Mild Hepatic Impairment)
Entospletinib administered twice daily on Days 1-4, and 1 morning dose only on Day 5.
干预措施: Entospletinib (Drug)
结局指标
主要结局
Pharmacokinetic (PK) Parameter: AUCtau of ENTO
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Pharmacokinetic (PK) Parameter: Cmax of ENTO
时间窗: 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 60, 72, 84, and 96 hours postdose on Day 5
Cmax is defined as the maximum concentration of drug.
次要结局
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)(Baseline up to Day 9 plus 30 days)
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities(Baseline up to Day 9 plus 30 days)