Key result
In conscious cynomolgus monkeys, none of the 6 negative compounds prolonged the QTcB interval, whereas 7 of 10 positive compounds significantly prolonged it.
Why the study?
Does oral administration of various drugs prolong the QTcB interval in conscious cynomolgus monkeys?
Population
Male cynomolgus monkeys weighing 3.0-7.0 kg (n=3-4 per compound group)
Comparison
Oral administration of 10 positive compounds and… vs Vehicle control
Design
Preclinical, Dose-escalation or Latin Square design
Follow-up
24 hours
Authors
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Supports cynomolgus monkey QTcB assay for preclinical safety screening; leaves open human translation pending clinical validation.
Does oral administration of various drugs prolong the QTcB interval in conscious cynomolgus monkeys?
In vivo QT assays in conscious cynomolgus monkeys represent a useful model for assessing the risks of drug-induced QT interval prolongation in safety pharmacology studies.
Ando et al. (2005) studied Drug-induced QT interval prolongation. 16 reference compounds (10 positive, 6 negative) vs. Vehicle was evaluated on QTcB interval prolongation. In conscious cynomolgus monkeys, none of the 6 negative compounds prolonged the QTcB interval, whereas 7 of 10 positive compounds significantly prolonged it.
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