Investigating the Exposure of NNC0487-0111 in Different Oral Formulations and the Effect of Food Intake on Pharmacokinetics of NNC0487-0111 in Participants With Overweight or Obesity
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 1
- 主要终点
- Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
研究概览
简要总结
This study consists of two phases: Phase A and Phase B. Participants are being asked to participate in both phases. Phase A of this study is comparing two formulations of a study medicine called NNC0487-0111 for weight control in people with overweight or obesity. Phase B of this study is testing how taking NNC0487-0111 at the same time as a meal affects the way NNC0487-0111 works in participants body. The aim of this study is to compare how two different formulations of NNC0487-0111 behave in the body, and how their function is affected when they are taken with or without a meal. Participants will either get NNC0487-0111 Formulation C, or NNC0487-0111 Formulation D. Both formulations are given as tablets. Which treatment participants get is decided by chance. Oral NNC0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. The study will last for about 5 - 6 months (155-184 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Phase A: single-blinded to the investigator Phase B: open label
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
- •Age 18-64 years (both inclusive)
- •Body mass index (BMI) between 27.0 and 39.9 kilogram per meter square (kg/m^2) (both inclusive)
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator
排除标准
- •Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
- •Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values:
- •Vitamin D (25-hydroxycholecalciferol) less than (<) 12 ng/mL (30 Nanometer (nM)) at screening
- •Parathyroid hormone (PTH) outside normal range at screening
- •Total calcium outside normal range at screening
- •Calcitonin greater than or equal to (≥) 50 pg/mL at screening
- •Amylase greater than or equal to (≥) 2 times upper limit of normal
- •Lipase greater than or equal to (≥) 2 times upper limit of normal
- •Glycated hemoglobin (HbA1c) greater than or equal to (≥) 6.5 % (48 millimoles per mole (mmol/mol)) at screening
研究组 & 干预措施
Phase A: NNC0487-0111 (formulation D)
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation D) at increasing doses (the dose will be escalated every 3 weeks).
干预措施: NNC0487-0111 (formulation D) (Drug)
Phase A: NNC0487-0111 (formulation C)
Participants will receive once daily dose of six different dose levels (1-6) of NNC0487-0111 (formulation C) at increasing doses (the dose will be escalated every 3 weeks).
干预措施: NNC0487-0111 (formulation C) (Drug)
Phase B: NNC0487-0111 (formulation D)
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation D).
干预措施: NNC0487-0111 (formulation D) (Drug)
Phase B: NNC0487-0111 (formulation C)
Participants will receive once daily dose of dose level 6 of NNC0487-0111 (formulation C).
干预措施: NNC0487-0111 (formulation C) (Drug)
结局指标
主要结局
Phase A: The area under the NNC0487-0111 plasma concentration-time curve during a dosing interval at steady state
时间窗: From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126
Measured as hours\*nanomoles per liter (h\*nmol/L)
次要结局
- Phase A: The maximum observed plasma concentration of NNC0487-0111 at steady state(From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126)
- Phase A: The time from dose administration to maximum observed plasma concentration of NNC0487-0111 at steady state(From pre-dose to after dosing on days 21, 42, 63, 84, 105 and 126)
- Phase B: The area under the NNC0487-0111 plasma concentration-time curve(From pre-dose to after dosing on day 132)
- Phase B: The maximum plasma concentration of NNC0487-0111 after the last dose(From pre-dose to after dosing on day 132)
- Phase B: The time to maximum observed plasma concentration of NNC0487-0111 after the last dose(From pre-dose to after dosing on day 132)
- Phase B:The terminal half-life of NNC0487-0111 after the last dose(From pre-dose on day 132 until completion of the end of study visit (day 153))
- Number of treatment emergent adverse events (TEAE)(From time of trial product administration (Visit 2, day 1) until completion of the end of study visit (day 153))