Two-part Phase 1 study to assess the effect of single therapeutic and supra-therapeutic doses of lucerastat on the QT/QTc interval duration in healthy subjects (Part A: Pilot study; Part B: TQT study)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
44
2000 and 4000 mg; hard capsules for oral administration
hard capsules for oral administration
400 mg; film-coated tablets for oral administration
QPS Netherlands B.V.
Groningen, Netherlands
Part B: Placebo-corrected, change-from-baseline QTcF (ΔΔQTcF)
QTcF = QT interval corrected with Fridericia's formula; ΔΔQTcF = Placebo-corrected change-from-baseline QTcF
Time frame: From 1 h pre-dose to 36 hour after study treatment administration (duration: up to 37 hours)
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1000 mg; hard capsules for oral administration
4000 mg; hard capsules for oral administration