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

Last updated: July 24, 2025
Sponsor: Enanta Pharmaceuticals, Inc
Overall Status: Completed

Phase

1

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

zelicapavir (supratherapeutic dose)

Placebo

moxifloxacin

Clinical Study ID

NCT06601192
EDP 938-008
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 50kg

  • Heterosexually active male participants and their female partners of childbearingpotential must agree to use 2 effective birth control methods for the duration ofthe study and for 90 days after the last dose of study intervention.

  • Females of childbearing potential must agree to use 2 effective birth controlmethods for the duration of the study and for 30 days after the last dose of studyintervention.

Exclusion

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 orsubjects 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 theterminal 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

Study Design

Total Participants: 72
Treatment Group(s): 4
Primary Treatment: zelicapavir (supratherapeutic dose)
Phase: 1
Study Start date:
July 15, 2024
Estimated Completion Date:
February 25, 2025

Connect with a study center

  • ICON

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • ICON Early Phase, LLC

    San Antonio, Texas 78290
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.