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

Description

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.

Conditions

RSV Infection, QTc Interval

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
RSV Infection
Intervention / Treatment

-

Contacts and Locations

Lenexa

ICON, Lenexa, Kansas, United States, 66219

San Antonio

ICON Early Phase, LLC, San Antonio, Texas, United States, 78290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Enanta Pharmaceuticals, Inc,

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, Enanta Pharmaceuticals, Inc

Study Record Dates

2025-02