Phase 1, Randomized, Double-Blind Four-Period Crossover, Thorough QT/QTc Study to Evaluate the Effects of EDP-938 on Cardiac Repolarization in Healthy Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
研究概览
简要总结
The purpose of the study is to assess the effect of a therapeutic and supratherapeutic dose of zelicapavir on the corrected cardiac QT interval relative to a placebo and positive control in healthy participants.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An informed consent document signed and dated by the subject.
- •Male or female individuals who are 18 to 65 years of age, inclusive
- •Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
- •Heterosexually active male participants and their female partners of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 90 days after the last dose of study intervention.
- •Females of childbearing potential must agree to use 2 effective birth control methods for the duration of the study and for 30 days after the last dose of study intervention.
排除标准
- •Clinically relevant evidence or history of illness or disease
- •Clinically relevant risk factors for cardiovascular abnormalities
- •Pregnant or nursing females
- •History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
- •Infection with HIV, HBV, HCV, or SARS CoV 2
- •Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
- •Before the first dose of study intervention, participant has received any vaccine, an investigational agent or biological product within 28 days or 5 times the terminal half-life (t½), whichever is longer
- •A positive urine drug screen at Screening or Day -1
- •Current tobacco smokers or use of tobacco within 3 months prior to Screening
- •History of regular alcohol consumption
研究组 & 干预措施
zelicapavir Dose 1 (therapeutic dose)
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
干预措施: zelicapavir (therapeutic dose) (Drug)
zelicapavir Dose 2 (supratherapeutic dose)
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
干预措施: zelicapavir (supratherapeutic dose) (Drug)
placebo
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
干预措施: Placebo (Drug)
moxifloxacin
All participants will receive 4 study interventions. The study interventions will be administered during separate treatment periods starting on Days 1, 9, 17, and 25.
干预措施: moxifloxacin (Drug)
结局指标
主要结局
Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir
时间窗: Up to 24 hours post dose
次要结局
- Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir(Up to 24 hours post dose)
- Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir(Up to 24 hours post dose)
- Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir(Up to 96 hours post dose)
- Cmax of zelicapavir(Up to 96 hours post dose)
- Tmax of zelicapavir(Up to 96 hours post dose)
- t1/2 of zelicapavir(Up to 96 hours post dose)
- Vd/F of zelicapavir(Up to 96 hours post dose)
- CL/F of zelicapavir(Up to 96 hours post dose)
- ΔΔQTcF after moxifloxacin dosing(Up to 24 hours post dose)
- Safety measured by adverse events(Up to Day 33)