An Open-Label, Parallel-Group Study to Compare the Pharmacokinetics, Safety and Tolerability of a Single Sublingual 1 mg Dose of AGO178 in Subjects With Mild and Moderate Hepatic Impairment With That in Matched Healthy Control Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Area Under the Plasma Curve (AUC) of AGO178
研究概览
简要总结
AGO178 was developed for the treatment of depression. A new formulation is being tested in the present study: a tablet to be placed and dissolved under the tongue (sublingual tablet). The goal of this trial was to study the pharmacokinetics of agomelatine given as sublingual tablet in participants with liver impairment and to compare the results to those of healthy volunteers who receive the same treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants with liver disease confirmed within 3 months of screening.
- •If liver impairment is caused by alcohol use, participants must have abstained from alcohol use within 3 months of study start.
- •Participants must satisfy criteria for Child- Pugh Class A or B.
排除标准
- •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
- •Pregnant or nursing (lactating) women.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless using effective contraception during the study.
- •Donation or loss of 400 millilitres (mL) or more of blood within eight (8) weeks prior to initial dosing.
- •Significant illness within the two weeks prior to the dosing.
- •Participants with Child-Pugh alterations due to a non-liver disease (e.g. cancer or treatment related weight loss).
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Mild Hepatic Impaired Participants
Mild hepatic impaired participants will receive a single sublingual dose of AGO178, 1 milligram (mg) on Day 1.
干预措施: AGO178 (Drug)
Moderate Hepatic Impaired Participants
Moderate hepatic impaired participants will receive a single sublingual dose of AGO178, 1 mg on Day 1.
干预措施: AGO178 (Drug)
Healthy Participants Matched by Aged, Gender and Body Mass Index (BMI)
Healthy participants matched by aged, gender and BMI will receive a single sublingual dose of AGO178, 1 mg on Day 1.
干预措施: AGO178 (Drug)
结局指标
主要结局
Area Under the Plasma Curve (AUC) of AGO178
时间窗: Predose, 2 min , 5 min , 10 min, 20 min, 30 min, 45 min, 1h, 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose
Blood samples will be collected at various time points on day 1 and day 2
Maximum Observed Plasma Concentration (Cmax) of AGO178
时间窗: Predose, 2 minute (min) , 5 min , 10 min, 20 min, 30 min, 45 min, 1 hour (h), 1.5h, 2h, 3h, 4h, 6h, 12h, 24h, 36h Post dose
Blood samples will be collected at various time points on day 1 and day 2
次要结局
- Number of Participants with Adverse Events(Baseline and Day 8)