NCT06601192

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	zelicapavir (therapeutic dose)	Subjects will receive zelicapavir (TD) once per treatment period.
DRUG	zelicapavir (supratherapeutic dose)	Subjects will receive zelicapavir (SD) once per treatment period.
DRUG	Placebo	Subjects will receive zelicapavir matching placebo once per treatment period.
DRUG	moxifloxacin	Subjects will receive moxifloxin once per treatment period.

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-02-02
• Completion: 2025-02-25
• First posted: 2024-09-19
• Last updated: 2025-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study