The Effect of Moderate Hepatic Impairment on the Pharmacokinetics Following Single-Dose Inhaled Administration of TD-4208
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Mylan Inc.
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Maximum observed plasma 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 TD-4208.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
- •For normal hepatic function group: Subject is in good health
排除标准
- •Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
- •Subject has received an investigational drug (or medical device) within 30 days
- •Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
研究组 & 干预措施
Hepatic Impairment
Eight subjects with Moderate Hepatic Impairment (Child-Pugh B). Drug: TD-4208 175mcg, inhaled, single dose.
干预措施: TD-4208 (Drug)
Normal Hepatic Function
Eight healthy participants matched to participants with moderate hepatic impairment. Drug: TD-4208 175mcg, inhaled, single dose.
干预措施: TD-4208 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Predose; 5min, 15min, 30 min; 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 24hr, 36hr, 48hr, 72hr, 96hr post dose
TD-4208 Cmax, derived from plasma concentration-time curves
次要结局
- Adverse Events (AE)(From the time of study drug administration through the end of the study (Day 5 or early termination))