Investigation of Pharmacokinetics, Safety and Tolerability of a Single Subcutaneous Dose of NNC0194-0499 in Participants With Various Degrees of Hepatic Impairment and Normal Hepatic Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 5
- 主要终点
- AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
研究概览
简要总结
The study medicine NNC0194-0499 is under development for non-alcoholic fatty liver disease (NAFLD) including non-alcoholic steatohepatitis (NASH). All participants will receive a single dose of 30 milligram (mg) of the study medicine. The study medicine will be given in the form of an injection of 0.6 millilitres in a skinfold of the thigh (subcutaneous). The study will last for up to 64 days. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period. Women who are able to become pregnant must use highly effective contraception and will be counselled on the use of contraception. Participants with impaired liver function will undergo an ultrasound of the belly and measurement of brain activity.
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
- •Male or female.
- •Aged 18-80 years (both inclusive) at the time of signing informed consent.
- •Body mass index (BMI) between 18.5-39.9 kilogram per square meter (kg/m^2) (both inclusive). Specific inclusion criterion only for participants with hepatic impairment:
- •Participants with stable hepatic impairment classified as Child-Pugh grade A, B or C as assessed by the investigator. Stable hepatic impairment is defined as no clinically significant change in disease status, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
研究组 & 干预措施
Participants With Normal Hepatic Function
Participants with normal hepatic function will receive a single subcutaneous dose of 30 milligram (mg) of NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
Participants With Mild Hepatic Impairment
Participants with mild hepatic impairment (Child Pugh Grade A) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
Participants With Moderate Hepatic Impairment
Participants with moderate hepatic impairment (Child-Pugh Grade B) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
Participants With Severe Hepatic Impairment
Participants with severe hepatic impairment (Child-Pugh Grade C) will receive a single subcutaneous dose of 30 mg of NNC0194-0499 on Day 1.
干预措施: NNC0194-0499 (Drug)
结局指标
主要结局
AUC0-∞, Single Dose, NNC0194-0499: the area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose
时间窗: From 0 hours (Day 1) until end of study visit (Day 36)
Measured in nanomoles hour per liter (nmol h/L).
次要结局
- Cmax, NNC0194-0499: the maximum concentration of NNC0194-0499 in serum(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Number of treatment emergent adverse events (TEAEs)(From time of trial product administration (Visit 2, Day 1) until completion of the end of trial visit (Visit 8, Day 36))
- tmax, NNC0194-0499: the time from dose administration to maximum serum concentration of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- Vz/F, NNC0194-0499: apparent volume of distribution of NNC0194-0499 after a single dose(From Day 1 (pre-dose) until completion of the end of trial visit (Day 36))
- t1/2, NNC0194-0499: the terminal half-life of NNC0194-0499 in serum(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))
- CL/F, NNC0194-0499: the apparent total serum clearance of NNC0194-0499(From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36))