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
Abstract
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.
Primary outcome: Time-matched, placebo-corrected change-from-baseline QTc based on the Fridericia correction QTcF (ΔΔQTcF) after TD and SD of Zelicapavir.
Enrollment: 72 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 72 participants or records.
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