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OpenTrials
Completed

NCT Number: NCT06601192

A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON, Lenexa, Kansas, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

zelicapavir (therapeutic dose)

Drug

Subjects will receive zelicapavir (TD) once per treatment period.

Other names: EDP-938

zelicapavir (supratherapeutic dose)

Drug

Subjects will receive zelicapavir (SD) once per treatment period.

Other names: EDP-938

Placebo

Drug

Subjects will receive zelicapavir matching placebo once per treatment period.

moxifloxacin

Drug

Subjects will receive moxifloxin once per treatment period.

Primary outcomes

  1. Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir

    Time frame: Up to 24 hours post dose

Secondary outcomes

  1. Time-matched, placebo-corrected, change-from-baseline non-QT intervals after TD and SD of Zelicapavir

    Time frame: Up to 24 hours post dose

  2. Time-matched, placebo-corrected, change-from-baseline HR after TD and SD of Zelicapavir

    Time frame: Up to 24 hours post dose

  3. Concentration-QTc analysis based on the relationship between plasma concentrations of zelicapavir and ΔΔQTcF after a TD and SD of zelicapavir

    Time frame: Up to 96 hours post dose

  4. Cmax of zelicapavir

    Time frame: Up to 96 hours post dose

  5. Tmax of zelicapavir

    Time frame: Up to 96 hours post dose

  6. t1/2 of zelicapavir

    Time frame: Up to 96 hours post dose

  7. Vd/F of zelicapavir

    Time frame: Up to 96 hours post dose

  8. CL/F of zelicapavir

    Time frame: Up to 96 hours post dose

  9. ΔΔQTcF after moxifloxacin dosing

    Time frame: Up to 24 hours post dose

  10. Safety measured by adverse events

    Time frame: Up to Day 33

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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