Lack of effect of favipiravir, a novel antiviral agent, on QT interval in healthy Japanese adults.
Int J Clin Pharmacol Ther
; 53(10): 866-74, 2015 Oct.
Article
in En
| MEDLINE
| ID: mdl-26308176
ABSTRACT
OBJECTIVE:
A thorough QT study of favipiravir, a novel antiviral agent, was conducted using a randomized, doubleblind, 4-group, 4-period crossover, placebo-and positive-controlled (open-label moxifloxacin) design. MATERIALS ANDMETHODS:
56 healthy Japanese adults of both sexes received single oral doses of favipiravir 1,200 and 2,400 mg (Avigan® Tablets, Toyama Chemical Co., Ltd.), moxifloxacin 400 mg, and a placebo. QT intervals after these treatments were measured under blinded conditions. The primary endpoint was the time-matched, placebo-adjusted change in corrected QT intervals using the Fridericia method (QTcF) from predose for favipiravir or moxifloxacin (ΔΔQTcF).RESULTS:
Lower bounds of the two-sided 90% confidence interval of ΔΔQTcF values for moxifloxacin exceeded 3 msec at all time points, and the maximum value was 14.0 (11.8-16.1, 90% confidence interval) msec at 3 hours after administration. Similarly, maximum ΔΔQTcF values for favipiravir were 0.833 (-1.33-3.00) msec at 3 hours after administration of 1,200 mg, and 0.500 (-1.88-2.88) msec at 6 hours after administration of 2,400 mg. Calculation of the sample size using the ΔΔQTcF value of moxifloxacin indicated that 25 subjects would be sufficient for detection at a power of 90% or higher, which meets the criteria for assuring assay sensitivity.CONCLUSIONS:
It is possible to use a smaller number of subjects in thorough QT studies in Japan than in Europe and the US utilizing moxifloxacin as a positive control. There were no detectable effects of favipiravir on the QT/QTc interval.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Antiviral Agents
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Pyrazines
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Electrocardiography
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Amides
Type of study:
Clinical_trials
Limits:
Adult
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Female
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Humans
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Male
Language:
En
Journal:
Int J Clin Pharmacol Ther
Journal subject:
FARMACOLOGIA
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TERAPIA POR MEDICAMENTOS
Year:
2015
Document type:
Article