An Open Label, Phase 1 Study to Evaluate the Effect of Mile and Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Cenicriviroc (CVC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Multiple-dose pharmacokinetics of CVC
研究概览
简要总结
To determine whether CVC exposures are altered in subjects with impaired hepatic function, compared to subjects with normal hepatic function. The results will help guide the clinical use of CVC in patients with hepatic impairment, determine the extent of PK changes, if any, and identify the potential need for dose adjustments of CVC in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and non-pregnant, non-lactating females aged 18-65
- •Weight ≥ 50.0 kg
- •BMI 18.0 - 40.0 kg/m2
- •Able to participate, and willing to give written informed consent and to comply with the study restrictions
- •Subjects with hepatic impairment will have stable liver disease (Child Pugh A or Child Pugh B)
排除标准
- •Pregnant or lactating women and male partners of women who are pregnant or lactating
- •Uncontrolled treated or untreated hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 105 mmHg)
- •QTcF > 450 msec for males and > 470 msec for females at Screening or Day -1
- •Donation or loss of blood over 350 mL within 60 days prior to screening
- •Any evidence of progressive liver disease within the last 4 weeks for subjects with hepatic impairment
研究组 & 干预措施
Cenicriviroc in mild liver impaired
Subjects with mild liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.
干预措施: Cenicriviroc in mild liver impaired (Drug)
Cenicriviroc in moderate liver impaired
Subjects with moderate liver impaired will receive cenicriviroc, 1 tablet once daily, for 14 days. Matching healthy subjects will receive Cenicriviroc, 1 tablet once daily, for 14 days.
干预措施: Cenicriviroc in moderate liver impaired (Drug)
结局指标
主要结局
Multiple-dose pharmacokinetics of CVC
时间窗: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose on Days 1 and 14
Intensive PK on Days 1 and 14. Trough PK on Days 3-13. Additional free (unbound) CVC will be assessed 2 hours and 24 hours postdose on Day 14.
次要结局
- Safety and tolerability(Days 1 through 35 for hepatic impaired subjects and Days 1-28 for healthy matching subjects)