A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Number of treatment emergent adverse events
研究概览
简要总结
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects
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
- Double (Participant, Investigator)
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
- •Male aged 18-55 years (both inclusive) at the time of signing informed consent
- •Body mass index (BMI) between 18.5-28.0 kg/m^2 (both inclusive)
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs and clinical laboratory tests performed during the screening visit, as judged by the investigator
- •Normal electrocardiogram (ECG) at screening or minor findings considered not clinically significant, as judged by the investigator
排除标准
- •Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per week), or subject smoking equal to or less than 5 cigarettes or the equivalent per week who is not able or willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to each dosing and during the in-patient periods
- •Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
- •Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic
- •History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy,gastric bypass surgery)
研究组 & 干预措施
Part A, SNAC
Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants.
干预措施: SNAC (Drug)
Part A, placebo
Single dose at corresponding dose levels.
干预措施: Placebo (Drug)
Part B, SNAC, Placebo, Moxifloxacin
Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.
干预措施: SNAC (Drug)
Part B, SNAC, Placebo, Moxifloxacin
Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.
干预措施: Placebo (Drug)
Part B, SNAC, Placebo, Moxifloxacin
Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Number of treatment emergent adverse events
时间窗: From dosing (day 1) to follow-up (days 8-11)
PART A
The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
时间窗: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours
PART B
次要结局
- Maximum observed SNAC plasma concentration(From 0 to 12 hours)
- Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP)(At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours)
- Area under the SNAC plasma concentration time curve(From 0 to 12 hours)