Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area under the somapacitan serum concentration time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to investigate the effect of abnormal liver (hepatic) function on the amount of trial drug getting into the body and removal of the drug from the body (this is called pharmacokinetics).
In this trial the participants will receive three subcutaneous (under the skin) injections of the trial drug somapacitan. Somapacitan is a long-acting growth hormone analogue (a drug similar to human growth hormone) intended for once-weekly subcutaneous administration.
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
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures
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
- •Male or female aged 18-75 years (both inclusive)
- •Body mass index of 18.5-39.9 kg/sqm (both inclusive)
- •Subjects with normal hepatic function or hepatic impairment (mild or moderate)
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice) for at least 16 days after the last trial product administration
- •Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration
- •Any blood draw in excess of 25 mL in the past 30 days, or donation of blood or plasma in excess of 400 mL within the 90 days preceding screening
- •Any disorder, except for conditions associated with hepatic impairment in the group of subjects with compromised hepatic function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
研究组 & 干预措施
Normal hepatic function
Subjects with normal hepatic function
干预措施: Somapacitan (Drug)
Mild hepatic impairment
Subjects with mild hepatic impairment
干预措施: Somapacitan (Drug)
Moderate hepatic impairment
Subjects with moderate hepatic impairment
干预措施: Somapacitan (Drug)
结局指标
主要结局
Area under the somapacitan serum concentration time curve
时间窗: From time 0 to 168 hours after the last dosing on Day 15
Calculated based on somapacitan measured in blood
次要结局
- Time to maximum serum concentration of somapacitan(After the last dosing on Day 15 until Day 43)
- Incidence of adverse events(From first dosing to Day 43)
- Occurrence of anti-somapacitan antibodies(From Day 0 to Day 43)
- Maximum serum concentration of somapacitan(After the last dosing on Day 15 until Day 43)