Thorough QT Study to Evaluate the Effects of Single Doses of Vicadrostat on Cardiac Safety Parameters in Healthy Male and Female Subjects (a Randomized, Placebo-controlled, Double-blind, Five-period Crossover Study With Open-label Moxifloxacin as Positive Control)
Abstract
The main objective of this trial is to investigate the effect of vicadrostat on the heart compared with placebo in healthy male and female volunteers.
Conditions: Healthy.
Primary outcome: The maximum mean difference between each single dose of either low or high dose of vicadrostat and placebo in QTcF changes from baseline between 20 min to 24 hours after drug administration.
Enrollment: 45 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: 45 participants or records.
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