A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
研究概览
简要总结
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
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 64 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Aged 18-64 years (both inclusive) at the time of signing informed consent
- •Body mass index between 20.0 and 32.0 kilogram per meter square (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 of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
研究组 & 干预措施
Sequence 1
Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 G (Drug)
Sequence 1
Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 B (Drug)
Sequence 2
Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 G (Drug)
Sequence 2
Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 F (Drug)
Sequence 3
Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 F (Drug)
Sequence 3
Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 B (Drug)
Sequence 4
Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 G (Drug)
Sequence 4
Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 F (Drug)
Sequence 5
Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 G (Drug)
Sequence 5
Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 B (Drug)
Sequence 6
Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 F (Drug)
Sequence 6
Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2).
干预措施: NNC0385-0434 B (Drug)
结局指标
主要结局
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
时间窗: From 0 to 24 hours after dose administration on visit 2, day 10
Measured in h \* nmol/L
次要结局
- Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434(From 0 to 24 hours after dose administration on visit 2, day 10)
- tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434(From 0 to 24 hours after dose administration on visit 2, day 10)