A Phase 1, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of FG-4592 in Subjects With Moderate Hepatic Impairment and Healthy Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameter of FG-4592 in plasma as measured by area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf)
研究概览
简要总结
The effect of moderately diminished liver function on the exposure, safety and tolerability of a single dose of FG-4592 is studied in male and female subjects. The results are compared to the data gained from subjects with normal liver function.
详细描述
The effect of moderate hepatic impairment on the pharmacokinetics (PK), safety and tolerability of a single dose of FG-4592 in male and female subjects is investigated. Data obtained from these subjects are compared to data from BMI-, age- and sex-matched subjects with normal hepatic function. Both groups consist of 8 subjects.
Screening takes place from Days -22 to -2 before admission to the clinical unit on Day -1. Administration of the trial medication takes place on Day 1 under fasted conditions. Healthy subjects are discharged on Day 5 and subjects with moderate hepatic impairment on Day 7, if there is no reason to extend the stay. An end-of-study visit (ESV) takes place 5 to 9 days after (early) discharge.
Safety assessments are performed throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both healthy subjects and subjects with moderate hepatic impairment:
- •Independent Ethics Committee (IEC)-approved written Informed Consent and privacy language as per national regulations must be obtained from the subject prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
- •Male subjects and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period and for 90 days after the study drug administration.
- •In addition, subjects with moderate hepatic impairment must also meet the following inclusion criteria:
- •Subject has Child-Pugh classification Class B (moderate, 7 to 9 points) liver function impairment [screening].
排除标准
- •Both healthy subjects and subjects with moderate hepatic impairment:
- •Female subject who has been pregnant within 6 months prior to screening or breastfeeding within 3 months before screening.
- •Subject has a known or suspected hypersensitivity to FG-4592, or any components of the formulation used.
- •In addition, healthy subjects must also NOT meet the following exclusion criteria:
- •Subject has any of the liver function tests (LFT) (Aspartate Aminotransferase [AST], Alanine Aminotransferase [ALT], Alkaline Phosphatase [ALP], Gamma Glutamyl Transferase [GGT], Total Bilirubin [TBL] above the upper limit of normal (ULN). In such a case the assessment may be repeated once [Day-1].
- •In addition, subjects with moderate hepatic impairment must also NOT meet the following exclusion criteria:
- •Subject had a previous liver transplantation.
研究组 & 干预措施
1: FG-4592 in subjects with moderate hepatic impairment
干预措施: FG-4592 (Drug)
2: FG-4592 in healthy subjects
干预措施: FG-4592 (Drug)
结局指标
主要结局
Pharmacokinetic parameter of FG-4592 in plasma as measured by area under the concentration-time curve (AUC) extrapolated to infinity (AUCinf)
时间窗: Days 1 to 5 (Day 7 for hepatic impaired subjects)
Pharmacokinetic parameter of FG-4592 in plasma as measured by maximum concentration (Cmax)
时间窗: Days 1 to 5 (Day 7 for hepatic impaired subjects)
次要结局
- Pharmacokinetic profile of FG-4592 in plasma(Days 1 to 5 (Day 7 for hepatic impaired subjects))
- Pharmacokinetic profile of FG-4592 in urine(Days 1 to 5 (Day 7 for hepatic impaired subjects))
- Erythropoietin in plasma(Days 1 to 5 (Day 7 for hepatic impaired subjects))
- Safety and tolerability of FG-4592(Screening (Days -22 to -2) to ESV (5 to 9 days after (early) discharge))