A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 2
- 主要终点
- AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
研究概览
简要总结
In this study, four new tablet versions of two compounds will be investigated.
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance.
Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days.
The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 18-55 years (both inclusive) at the time of signing informed consent.
- •Body mass index between 20.0 and 29.9 kg/m^2 (both inclusive).
- •Considered to be generally healthy 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
- •Known or suspected hypersensitivity to study interventions or related products.
- •Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
- •Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- •History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
研究组 & 干预措施
Part B: NNC0385-0434
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: NNC0385-0434 E (Drug)
Part A: Oral semaglutide
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: Semaglutide D (Drug)
Part A: Oral semaglutide
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: Semaglutide G (Drug)
Part A: Oral semaglutide
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: Semaglutide H (Drug)
Part A: Oral semaglutide
Four different formulations of oral semaglutide are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: Semaglutide I (Drug)
Part B: NNC0385-0434
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: NNC0385-0434 B (Drug)
Part B: NNC0385-0434
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: NNC0385-0434 C (Drug)
Part B: NNC0385-0434
Four different formulations of NNC0385-0434 are investigated. One formulation given for 10 days before participants receive a different formulation for 5 days
干预措施: NNC0385-0434 D (Drug)
结局指标
主要结局
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
时间窗: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
h \* nmol/L
次要结局
- Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose(From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration)
- tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API(From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration)