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document
QT/QTc study conducted in Japanese adult healthy subjects : a novel xanthine oxidase inhibitor topiroxostat was not associated with QT prolongation . A QT/QTc study was conducted in compliance with ICH E14 guideline to evaluate the effects of a new xanthine oxidase inhibitor topiroxostat in Japanese healthy subjects . Forty-eight Japanese healthy subjects ( males 24 ; females 24 ) received a single oral dose of topiroxostat ( 60 or 180 mg ) , moxifloxacin ( 400 mg ) or placebo in a single-center , double-blind , four-period crossover design . Fridericia 's formula ( QTcF = QT/RR ( 0.33 ) ) was used as a primary method for QT-interval correction . The mean QTcF was prolonged by moxifloxacin , of which largest time-matched difference from placebo administration was 13.6 milliseconds with 90 % confidence interval ( CI ) of 11.2 and 15.9 milliseconds at 4 hours post-dose . The mean QTcF was hardly affected by either dose of topiroxostat , of which largest time-matched difference from placebo administration was 2.9 milliseconds with 90 % CI of 0.6 and 5.3 milliseconds at 4 hours post-dose for 60 mg , and 2.3 milliseconds with 90 % CI of 0 and 4.7 milliseconds at 1 hour post-dose for 180 mg . The results were essentially the same in the sex subgroup analysis . Moxifloxacin can be used as a positive control for QT/QTc studies in Japanese subjects ; and topiroxostat may not cause QT-interval prolongation in males as well as females .
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Intervention_Pharmacological
topiroxostat
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Intervention_Pharmacological
new xanthine oxidase inhibitor topiroxostat
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Intervention_Pharmacological
oral dose of topiroxostat
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Outcome_Physical
Fridericia 's formula ( QTcF = QT/RR ( 0.33 )
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Outcome_Physical
QT-interval correction
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Participant_Condition
Japanese
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Participant_Age
adult
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Participant_Condition
healthy subjects :
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Participant_Condition
Japanese healthy subjects