Investigation of Pharmacokinetics of 2 Different Formulations of NNC0519-0130 in Adult Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)
研究概览
简要总结
This study will look into a new study medicine called NNC0519-0130 to improve the treatment option for people living with excess body weight or type 2 diabetes or both. The purpose of this study is to compare the amount of NNC0519-0130 in the blood of participants who have excess body weight. The study comprises two parts and the participants will receive both preparations NNC0519-0130 B and NNC0519-0130 C, which treatment the participants get is decided by chance. The study will last for about 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female of non-childbearing potential.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body Mass Index (BMI) between 27.0 kilogram per square meter (kg/m^2) and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole [mmol/mol]) at screening.
- •Use of prescription medicinal products or nonprescription drugs, except routine vitamins, occasional use of acetaminophen, ibuprofen, acetylsalicylic acid, or topical medication (including eye drops for pupil dilation) not reaching systemic circulation, within 14 days before screening.
- •Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
研究组 & 干预措施
Part 1a: NNC0519-0130 C and NNC0519-0130 B
Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
干预措施: NNC0519-0130 B (Drug)
Part 1a: NNC0519-0130 C and NNC0519-0130 B
Participants will start treatment with formulation NNC0519-0130 C and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
干预措施: NNC0519-0130 C (Drug)
Part 1b: NNC0519-0130 B and NNC0519-0130 C
Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
干预措施: NNC0519-0130 B (Drug)
Part 1b: NNC0519-0130 B and NNC0519-0130 C
Participants will start treatment with formulation NNC0519-0130 B and receive a pre-determined dose escalation regimen of NNC0519-0130 B and NNC0519-0130 C.
干预措施: NNC0519-0130 C (Drug)
Part 2a: NNC0519-0130 B and NNC0519-0130 C
Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.
干预措施: NNC0519-0130 B (Drug)
Part 2a: NNC0519-0130 B and NNC0519-0130 C
Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 B then NNC0519-0130 C.
干预措施: NNC0519-0130 C (Drug)
Part 2b: NNC0519-0130 C and NNC0519-0130 B
Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.
干预措施: NNC0519-0130 B (Drug)
Part 2b: NNC0519-0130 C and NNC0519-0130 B
Participants will receive a pre-determined dose escalation regimen of NNC0519-0130 B in run-in period followed by treatment with NNC0519-0130 C then NNC0519-0130 B.
干预措施: NNC0519-0130 C (Drug)
结局指标
主要结局
AUC,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve during a dosing interval at steady state (SS)
时间窗: From pre-dose up to 7 days post-dose
Measured in hours\*nanomoles per liter (h\*nmol/L).
次要结局
- Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 at steady state(From pre-dose up to 7 days post-dose)
- Number of adverse events(From time of first dosing (day 1) until completion of the end of study visit (day 141/162))