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临床试验/NCT06601192
NCT06601192已完成1 期

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

Enanta Pharmaceuticals, Inc2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年7月15日最近更新:
适应症
干预措施
相关药物

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

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)

Experimental

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)

Experimental

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

Placebo Comparator

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

Experimental

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)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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