An Open-label, Single Arm, Sequential, Single Centre Trial Investigating the Influence of Oral Semaglutide (NNC0113-0217) on Pharmacokinetics of Lisinopril and Warfarin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Area under the S-warfarin concentration-time curve
研究概览
简要总结
This trial is conducted in Europe. The aim of the trial is to investigate the influence of oral semaglutide (NNC0113-0217) on the pharmacokinetics of lisinopril and warfarin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 18-75 years (both inclusive) at time of signing informed consent
- •Body mass index 20.0-29.9 kg/m^2 (both inclusive)
- •A good general health based on medical history, physical examination, and results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
排除标准
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods. Female of child bearing potential must use effective methods of birth control for the duration of the trial and for 5 weeks following last dose. Only highly effective methods of birth control are accepted (i.e. one that results in a less than 1% per year failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives, and some intrauterine devices)
- •History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease
- •Hypertension (defined as sitting systolic blood pressure above 140 mmHg and/or diastolic blood pressure above 90 mmHg). If white-coat hypertension is suspected at the screening visit, a repeated measurement is allowed
- •Any blood draw in excess of 50 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
研究组 & 干预措施
Victim and perpetrator compounds
Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.
干预措施: semaglutide (Drug)
Victim and perpetrator compounds
Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.
干预措施: lisinopril (Drug)
Victim and perpetrator compounds
Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.
干预措施: warfarin (Drug)
Victim and perpetrator compounds
Subjects receive two different victim compounds (lisinopril and warfarin) and two different perpetrator compounds (placebo semaglutide with carrier and oral semaglutide). Each dosing occasion is separated by a 7-day wash-out period.
干预措施: placebo (Drug)
结局指标
主要结局
Area under the S-warfarin concentration-time curve
时间窗: From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points
Area under the R-warfarin concentration-time curve
时间窗: From dosing to infinity calculated from a 0-168 hours S-warfarin concentration-time-curve based on 18 sampling time points
Area under the lisinopril concentration-time curve
时间窗: From dosing to infinity calculated from a 0-60 hours lisinopril concentration-time-curve based on 13 sampling time points
次要结局
- Maximum observed S-warfarin plasma concentration(0 to 168 hours after single dose)
- Maximum observed R-warfarin plasma concentration(0 to 168 hours after single dose)
- Maximum observed lisinopril plasma concentration(0 to 60 hours after single dose)