A Phase 1 Clinical Trial to Evaluate QTcF Prolongation and Proarrhythmic Potential of the Non Antiarrhythmic Drug Delgocitinib Following Oral Administration in Healthy Subjects
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change from baseline QTcF (ΔQTcF)
研究概览
简要总结
The purpose of this trial is to investigate the effects of delgocitinib, taken as a capsule, on the heart rhythms of healthy people, compared to a placebo.
详细描述
The trial will be performed in two parts.
- Part 1: Group 1 (dose 1 or placebo) and Group 2 (dose 2 or placebo)
- Part 2: Group 3 (dose 3 or placebo) and Group 4 (dose 4 or placebo)
The doses in Part 2 may be adjusted depending on the results of Part 1.
Participants will be screened within 28 days of their dose. Participants will stay in the clinic from Day -1 to Day 2 (1 day postdose) and will be dosed on Day 1. A follow up phone call will take place 2 week (±2 days) after dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index of ≥18.0 and <30.0 kg/m
- •In good health, as judged by the investigator based on: medical history, physical examination, vital sign assessment, clinical laboratory evaluations .
- •ECG without any clinically relevant abnormal findings at both screening and baseline
- •No history of additional risk factors for torsades de pointes (for example, heart failure, hypokalaemia, family history of long QT syndrome).
- •Female subjects of childbearing potential and male subjects with a female partner of childbearing potential must be willing to use highlly effective methods of contraception.
排除标准
- •Any disorder which is not stable and could:
- •Affect the safety of the subject throughout the trial.
- •Influence the findings of the trial.
- •Impede the subject's ability to complete the trial.
- •Use of any medication known to prolong the QT/QTc interval within 3 months or 5 half-lives of the drug, whichever is longer, prior to randomisation.
- •Any medications, including St. John's wort, known to chronically alter drug absorption or elimination processes within 30 days prior to dosing.
- •Current use of combined hormone contraceptives or combined hormonal replacement therapy.
- •Subjects who have smoked (use of any type of tobacco and nicotine containing products) within the last 3 months prior to screening.
- •History of chronic alcohol or drug abuse within 12 months prior to screening.
- •Receipt of any vaccine approved for SARS-CoV-2 within 4 weeks prior to baseline and/or 2 weeks after dose.
- •Receipt of live, attenuated vaccines within 4 weeks prior to baseline.
研究组 & 干预措施
Placebo
Delgocitinib placebo capsule
干预措施: Placebo capsule (Drug)
Active dose 1
Delgocitinib capsule (Dose 1)
干预措施: Delgocitinib capsule (Drug)
Active dose 2
Delgocitinib capsule (Dose 2)
干预措施: Delgocitinib capsule (Drug)
Active dose 3
Delgocitinib capsule (Dose 3)
干预措施: Delgocitinib capsule (Drug)
Active dose 4
Delgocitinib capsule (Dose 4)
干预措施: Delgocitinib capsule (Drug)
结局指标
主要结局
Change from baseline QTcF (ΔQTcF)
时间窗: predose to 24 hours postdose
Replicate electrocardiograms (ECGs) (10 ECG replicates) for the determination of ΔQTc interval will be extracted from the continuous digital 12-lead ECG recording
次要结局
- Frequency of treatment emergent changes in T-wave morphology.(predose to 24 hours postdose)
- Placebo-corrected change from baseline QTcF (ΔΔQTcF)(predose to 24 hours postdose)
- Placebo-corrected, change from baseline of Heart Rate (ΔΔHR)(predose to 24 hours postdose)
- Placebo-corrected, change from baseline of Pulse Rate (ΔΔPR)(predose to 24 hours postdose)
- Change from baseline of Heart Rate (ΔHR)(predose to 24 hours postdose)
- Change from baseline of Pulse Rate (ΔPR)(predose to 24 hourse postdose)
- Change from baseline of QRS interval (ΔQRS)(predose to 24 hours postdose)
- Placebo-corrected, change from baseline of QRS interval (ΔΔQRS)(predose to 24 hours postdose)
- Number of treatment emergent adverse events(dosing to day 15)
- Frequency of treatment emergent changes in U-waves presence(predose to 24 hours postdose)
- Categorical outliers for QTcF, HR, PR interval, and QRS duration.(predose to 24 hours post-dose)