A Phase 1, Two-Part, Open-Label, Parallel-Cohort, Single-Dose Study to Determine the Pharmacokinetics of T-817MA in Adult Subjects With Hepatic Impairment and in Healthy Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration time curve (AUC)
研究概览
简要总结
The primary objective is to determine the single-dose pharmacokinetics (PK) of T-817 and T-817M5 (metabolite of T-817) in subjects with mild, moderate or severe hepatic impairment compared to matched healthy control subjects.
The secondary objective is to determine the safety and tolerability of single-dose T -817MA (Maleate salt of T-817) in subjects with mild, moderate or severe hepatic impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For subjects with mild, moderate or severe hepatic impairment
- •Adult male or female, 18 - 75 years of age
- •Must weigh at least 50 kg and have a body mass index (BMI) ≥ 18.5 and ≤ 40.0 kg/m2
- •Have mild, moderate or severe defined by Child-Pugh classification hepatic impairment
- •For Matched Healthy Control Subjects Healthy adult male or female subjects will be matched 1:1 to a specific subject in the mild, moderate, or severe hepatic impairment cohort based upon age, weight, gender, and smoking status
排除标准
- •Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
- •History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI.
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug, related compounds, or inactive ingredients.
- •Female subjects who are pregnant or lactating.
研究组 & 干预措施
Cohort 1:T-817MA
Mild hepatic impairment subjects
干预措施: T-817MA (Drug)
Cohort 2:T-817MA
Healthy subjects matched to subjects in Cohort 1
干预措施: T-817MA (Drug)
Cohort 3:T-817MA
Moderate hepatic impairment subjects
干预措施: T-817MA (Drug)
Cohort 4:T-817MA
Healthy subjects matched to subjects in Cohort 3
干预措施: T-817MA (Drug)
Cohort 5 :T-817MA
Severe hepatic impairment subjects
干预措施: T-817MA (Drug)
Cohort 6:T-817MA
Healthy subjects matched to subjects in Cohort 5
干预措施: T-817MA (Drug)
结局指标
主要结局
Area under the plasma concentration time curve (AUC)
时间窗: 8 days
Plasma concentrations
时间窗: 8 days
Maximum observed plasma concentration (Cmax)
时间窗: 8 days
Apparent total plasma clearance of unbound drug after oral (extravascular) administration (CL/F)
时间窗: 8 days
Apparent volume of distribution during the terminal elimination phase after oral (extravascular) administration (Vd/F)
时间窗: 8 days
Metabolite to parent ratio (MPR)
时间窗: 8 days
Apparent terminal elimination rate constant
时间窗: 8 days
Time to reach the maximum observed plasma concentration (tmax)
时间窗: 8 days
Apparent terminal elimination half-life (t½)
时间窗: 8 days
次要结局
- Number of participants with treatment-related adverse events(8days)