Effects of Iclepertin on the QT Interval Following Oral Administration in Healthy Male and Female Subjects (a Double-blind, Randomised, Placebo-controlled, Multiple-dose, Parallel Group With Nested Crossover Design Trial, With Moxifloxacin as Positive Control)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point
研究概览
简要总结
This study aims to evaluate the effects of iclepertin in the range of therapeutic to supra-therapeutic exposures on the (QT/QTc): Electrocardiogram (ECG) time interval from the start of the QRS complex (ECG time interval) to the end of the T wave / QT interval corrected for heart rate, e.g. using the method of Fridericia or Bazett interval and other ECG parameters.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, ital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests without clinically significant abnormalities
- •Age of 18 to 50 years (inclusive)
- •Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
- •Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- •Either male subject, or female subject who meets any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
- •Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal, subdermal or transdermal), plus condom
- •Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
- •Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
- •Sexually abstinent
- •A vasectomized sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
- •Surgically sterilized (including hysterectomy)
- •Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L (or the reference range from the local safety laboratory) is confirmatory), hormone replacement therapy is not permitted Note: Male subjects are not required to use contraception.
排除标准
- •Subjects will not be allowed to participate, if any of the following general criteria apply:
- •Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
- •Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (Alanine transaminase (ALT), Aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the Upper limit of normal (ULN)
- •Any evidence of a concomitant disease assessed as clinically relevant by the investigator
- •Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- •Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
- •Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- •History of relevant orthostatic hypotension, fainting spells, or blackouts
- •Further exclusion criteria apply
研究组 & 干预措施
Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin
Placebo to moxifloxacin (Day 1) + Iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13
干预措施: Iclepertin (Drug)
Arm 1: Iclepertin treatment+ Placebo to Moxifloxacin
Placebo to moxifloxacin (Day 1) + Iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13
干预措施: Moxifloxacin Placebo (Drug)
Arm B1: Iclepertin Placebo treatment + Moxifloxacin
Moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1
干预措施: Iclepertin Placebo (Drug)
Arm B1: Iclepertin Placebo treatment + Moxifloxacin
Moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1
干预措施: Moxifloxacin (Drug)
Arm B1: Iclepertin Placebo treatment + Moxifloxacin
Moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Placebo to moxifloxacin (Day 13) - Arm B1
干预措施: Moxifloxacin Placebo (Drug)
Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin
Placebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2
干预措施: Iclepertin Placebo (Drug)
Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin
Placebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2
干预措施: Moxifloxacin (Drug)
Arm B2: Iclepertin Placebo treatment + Placebo to Moxifloxacin
Placebo to moxifloxacin (Day 1) + Placebo to iclepertin (Day 1-12) + Moxifloxacin (Day 13) - Arm B2
干预措施: Moxifloxacin Placebo (Drug)
结局指标
主要结局
QTcF change from baseline matched to the plasma concentration of iclepertin collected at the same time point
时间窗: Up to 12 days
QT interval corrected for heart rate, e.g. using the method of Fridericia (QTcF).
次要结局
- QTcF change from baseline matched to the plasma concentration of moxifloxacin collected at the same time point(Up to 1 day)