A Phase 1, Open Label, Nonrandomized, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of KBP-5074 in Subjects With Moderate Hepatic Impairment Compared to Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 3
- 主要终点
- Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
研究概览
简要总结
This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of KBP-5074.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, of any race, between 18 and 80 years of age, inclusive, at screening.
- •Body mass index between 18.0 and 40.0 kg/m2, inclusive, at screening.
- •Subjects with normal hepatic function must be in good health.
- •Subjects must meet the criteria for moderate hepatic impairment based on Child Pugh B.
排除标准
- •Significant history or clinical manifestation of any medical history, as determined by the investigator not appropriate to participate in this study.
- •Positive serology test results for hepatitis B surface antigen and/or human immunodeficiency virus 1/
- •Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives prior to dosing, whichever is longer.
- •Use of mineralocorticoids or MRAs (eg, spironolactone or eplenerone) within 90 days prior to study drug administration, unless deemed acceptable by the medical monitor and sponsor.
- •Subject has used prescription drugs within 30 days of study drug administration, with the exception of established therapy for hepatic disease and the treatment of associated disorders that have been stable for at least 30 days before study drug administration, as approved by the investigator and in consultation with the medical monitor.
研究组 & 干预措施
Hepatic Impaired
KBP-5074 0.5mg tablet orally, Single dose
干预措施: KBP-5074 (Drug)
Matched-control Healthy
KBP-5074 0.5mg tablet orally, Single dose
干预措施: KBP-5074 (Drug)
结局指标
主要结局
Pharmacokinetic Parameter: Maximum observed concentration (Cmax)
时间窗: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Maximum observed concentration (Cmax) - Plasma
Pharmacokinetic Paramete: Area under the concentration-time curve from time 0 to infinity (AUC0-∞)
时间窗: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Area under the concentration-time curve from time 0 to infinity (AUC0-∞) - Plasma
Safety of KBP-5074 by assessing the number of adverse events, laboratory abnormalities, ECGs, vital signs and physical examinations
时间窗: Up to 12 days
Incidence of severity of AEs, laboratory abnormalities (based on hematology, clinical chemistry, and urinalysis test results), ECGs, vital signs, and physical examinations
Pharmacokinetic Parameter: Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast)
时间窗: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Area under the plasma concentration time curve from time zero to time of last quantifiable concentration (AUC0-tlast) - Plasma
Pharmacokinetic Parameter: Time of the maximum observed concentration (tmax)
时间窗: 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, and 264 hours postdose.
Time of the maximum observed concentration (tmax) - Plasma
次要结局
未报告次要终点