A Randomized, Double-blind, Placebo-controlled, 4-way Crossover Study to Compare the Effects on the Cardiac De- and Repolarization Duration as Well as Other Cardiac Safety Parameters of Two Doses of Oral Lasmiditan (100 mg and 400 mg) With Those of Moxifloxacin (400 mg) and Placebo in Healthy Subjects
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
- Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
研究概览
简要总结
The purpose of this study was to determine how two doses of lasmiditan affected the heart in healthy participants. The study also evaluated how much lasmiditan got into the blood stream and how long it took the body to get rid of it. Information about side effects was collected. The study lasted a maximum of 46 days for each participant, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, 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 within 18.5 and 29.9 kilograms per meter squared (kg/m²)
- •In good physical and mental health as determined by the following:
- •Complete medical history
- •Complete physical examination
- •Vital signs including blood pressure (supine and standing), heart rate (supine and standing), respiratory rate, and temperature
- •Standard 12-lead ECG (triplicate ECG), followed by a 24-hour Holter ECG for arrhythmia monitoring
- •Clinical laboratory tests
排除标准
- •Any of the following cardiac abnormalities on safety screening ECG:
- •QTcF interval >430 milliseconds (ms) for males, >450 ms for females
- •Unusual T wave morphology or flattened low voltage T waves
- •PR interval >240 ms or <110 ms
- •Second-degree or third-degree atrioventricular block
- •ECG evidence of complete left or right bundle branch block
- •Intraventricular conduction delay or QRS duration >110 ms
- •Supine resting heart rate <45 beats per minute (bpm) or >90 bpm
- •Pathological Q-waves
- •Evidence of ventricular pre-excitation
- •Participants with a history of syncope, cardiac arrest, cardiac arrhythmia or torsade de pointes, or structural heart disease
- •Participants with a family history of Long QT syndrome
- •History of allergic hypersensitivity to lasmiditan or any component of the formulations
- •History or current evidence of abuse of any drug substance, licit or illicit, including alcohol; a positive urine screen for drugs of abuse
- •Participants with a history of postural hypotension or fainting
- •Participant is not able to understand and comply with study requirements, instructions and study restrictions
研究组 & 干预措施
100 milligrams (mg) Lasmiditan
A single, PO dose of 100 mg lasmiditan administered on Day 1 in one of four treatment periods.
干预措施: Lasmiditan (Drug)
400 mg Lasmiditan
A single, PO dose of 400 mg lasmiditan administered on Day 1 in one of four treatment periods.
干预措施: Lasmiditan (Drug)
Placebo
Placebo for lasmiditan and placebo for moxifloxacin administered on Day 1 in one of four treatment periods.
干预措施: Placebo (Drug)
Moxifloxacin
A single, PO dose of moxifloxacin administered on Day 1 in one of four treatment periods.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Change From Time Matched Baseline in Mean Fridericia-Corrected QT (QTcF) Values of Lasmiditan and Moxifloxacin
时间窗: Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTcF = QT/RR\^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and R-R wave (RR), which is the interval between two R waves. PR is the interval between the P wave and the ventricular depolarization wave (QRS) complex.
次要结局
- Change From Baseline in Mean Heart Rate (HR) of Lasmiditan and Moxifloxacin(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Number of Incidents in Electrocardiogram (ECG) Abnormalities in QTcF Interval Greater Than 450 Milliseconds(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Change From Baseline in Mean Cardiac Intervals:QRS of Lasmiditan and Moxifloxacin(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lasmiditan(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC-t) of Lasmiditan(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Change From Time Matched Baseline in Mean Individually-Corrected QT (QTcI) Values of Lasmiditan and Moxifloxacin(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)
- Change From Baseline in Mean Cardiac Intervals: RR Interval of Lasmiditan and Moxifloxacin(Day 1: Predose, 30 minutes postdose, 1 hour (hr), 1.5 hr, 2 hr, 2.5 hr, 3 hr, 3.5 hr, 4 hr, 6 hr, 8, hr, 12 hr and 24 hr postdose)