A Multiple-Ascending-Dose, Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled Study to Evaluate the Effect of ALXN2050 on the QT Interval in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050
研究概览
简要总结
This is a randomized, double-blind, double-dummy, placebo- and positive-controlled parallel study to evaluate the effect of ALXN2050 on the QT interval in healthy adult participants.
详细描述
Participants randomized to the treatment arm will receive ALXN2050 in a multiple-ascending doses fashion over 3 periods (treatment sequence ABC). Participants randomized to the control arms will be further randomized to 1 of 2 treatment sequences (treatment sequence DEF or GHI) to receive placebo or active control over 3 periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening.
- •No clinically significant history or presence of ECG abnormalities at screening.
- •Female participants must be of non-childbearing potential and need not employ a method of contraception.
- •Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
排除标准
- •Clinically significant laboratory abnormalities.
- •History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
- •History or presence of drug or alcohol abuse within previous 2 years, current tobacco and/or nicotine user, or positive alcohol and/or drug screen at screening or Day -1 of Period
- •History or presence of clinically significant seizures, head injury, or head trauma.
- •History of procedures that could alter absorption or excretion of orally administered drugs.
- •History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
- •History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
- •Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing.
- •Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, or receipt of blood products within 6 months prior to first dosing.
- •Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.
研究组 & 干预措施
Treatment Arm (ABC)
Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods:
Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo.
Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo.
Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo.
干预措施: ALXN2050 (Drug)
Treatment Arm (ABC)
Treatment Sequence ABC - Participants will receive all 3 doses of ALXN2050 in a multiple-ascending fashion over 3 periods:
Treatment A (Period 1): ALXN2050 Dose 120 milligrams (mg) and moxifloxacin-matching placebo.
Treatment B (Period 2): ALXN2050 Dose 240 mg and moxifloxacin-matching placebo.
Treatment C (Period 3): ALXN2050 Dose 360 mg and moxifloxacin-matching placebo.
干预措施: Moxifloxacin-matching Placebo (Drug)
Control Arm (DEF)
Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin.
Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
干预措施: ALXN2050-matching Placebo (Drug)
Control Arm (DEF)
Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin.
Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
干预措施: Moxifloxacin (Drug)
Control Arm (DEF)
Treatment Sequence DEF - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment D (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment E (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin.
Treatment F (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
干预措施: Moxifloxacin-matching Placebo (Drug)
Control Arm (GHI)
Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin.
Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin.
干预措施: ALXN2050-matching Placebo (Drug)
Control Arm (GHI)
Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin.
Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin.
干预措施: Moxifloxacin (Drug)
Control Arm (GHI)
Treatment Sequence GHI - Participants will receive ALXN2050-matching placebo over 3 periods:
Treatment G (Period 1): 120 mg ALXN2050-matching placebo and moxifloxacin.
Treatment H (Period 2): 240 mg ALXN2050-matching placebo and moxifloxacin-matching placebo.
Treatment I (Period 3): 360 mg ALXN2050-matching placebo and moxifloxacin.
干预措施: Moxifloxacin-matching Placebo (Drug)
结局指标
主要结局
Placebo-corrected Change From Baseline QTc Intervals (ddQTc) For ALXN2050
时间窗: Pre-dose through 24 hours post-dose
Twelve-lead electrocardiograms (ECGs) will be extracted from continuous (Holter) recordings.
次要结局
- Maximum Observed Plasma Concentration Following Multiple Dosing (Cmax,ss) For ALXN2050(Up to 24 hours postdose)
- Change From Baseline PR Interval (dPR) For ALXN2050(Pre-dose through 24 hours post-dose)
- Area Under The Plasma Concentration-time Curve During A Dosing Interval (tau) At Steady-state (AUCtau) For ALXN2050(Pre-dose through 24 hours post-dose)
- ddQTc For Moxifloxacin(Pre-dose through 24 hours post-dose)
- Time To Maximum Observed Plasma Concentration Following Multiple Dosing (Tmax,ss) For ALXN2050(Pre-dose through 24 hours post-dose)
- Incidence Of Treatment-emergent Adverse Events(Day 1 (postdose) through follow-up (7 [+/- 2] days after last study drug administration))