COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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

Quick Facts

Study Start:2024-07-15

Study Completion:2025-02-25

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06601192

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.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Principal Investigator

Enanta Pharmaceuticals, Inc

STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Study Locations (Sites)

ICON

Lenexa, Kansas, 66219

United States

ICON Early Phase, LLC

San Antonio, Texas, 78290

United States

Collaborators and Investigators

Sponsor: Enanta Pharmaceuticals, Inc

Enanta Pharmaceuticals, Inc, STUDY_DIRECTOR, Enanta Pharmaceuticals, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-15

Study Completion Date2025-02-25

Study Record Updates

Study Start Date2024-07-15

Study Completion Date2025-02-25

Terms related to this study

Additional Relevant MeSH Terms

RSV Infection
QTc Interval