Cardiovascular Abnormalities Clinical Trial
Official title:
A Single Dose, Double Blind, Randomized, Crossover Placebo- and Moxifloxacin (Open Label)-Controlled Study to Evaluate the Cardiac Effects of a Novel Food Ingredient in Healthy Male Subjects
This study evaluates if a single oral dose of 150 mg of the novel food ingredient (AME001, R,R-monatin) does not have an effect on the Fridericia-corrected QT ECG interval (QTcF) exceeding 10 milliseconds (msec). Each subject will consume test article (150 mg), placebo, and moxifloxacin (400 mg; positive control) in each of 3 treatment periods.
This study is specifically designed to evaluate the potential effects of ingestion of the
novel food ingredient on cardiac safety. The objective will be fulfilled by assessing
cardiac parameters including heart rate, blood pressure, and ECG/QT interval in healthy
adult male subjects following a single dose oral administration of the test article.
The primary objective of this study is to demonstrate that a single oral dose of 150 mg of
the test article does not have an effect on the Fridericia-corrected QT ECG interval (QTcF)
exceeding 10 milliseconds (msec).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
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