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

NCT06601192 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-008
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

RSV Infection; QTc Interval

Outcome Measures

Primary Outcomes (1)

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

  Up to 24 hours post dose

Secondary Outcomes (10)

• 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

Study Arms (4)

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.

Drug: zelicapavir (therapeutic dose)

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.

Drug: zelicapavir (supratherapeutic dose)

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.

Drug: Placebo

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.

Drug: moxifloxacin

Interventions

zelicapavir (therapeutic dose) DRUG

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

Also known as: EDP-938

zelicapavir Dose 1 (therapeutic dose)

zelicapavir (supratherapeutic dose) DRUG

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

Also known as: EDP-938

zelicapavir Dose 2 (supratherapeutic dose)

Placebo DRUG

Subjects will receive zelicapavir matching placebo once per treatment period.

placebo

moxifloxacin DRUG

Subjects will receive moxifloxin once per treatment period.

moxifloxacin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (2)

ICON

Lenexa, Kansas, 66219, United States

Location

ICON Early Phase, LLC

San Antonio, Texas, 78290, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938; Moxifloxacin

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: July 15, 2024
• Primary Completion: February 2, 2025
• Study Completion: February 25, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (2)