A study to assess the effect of single doses of daridorexant on electrocardiogram parameters in healthy subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
36
Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
Placebo administered as tablets for oral use.
Moxifloxacin administered as film-coated tablets for oral use.
CEPHA s.r.o.
Pilsen, Czechia
Placebo-corrected change from baseline in the HR-corrected QTcF (ΔΔQTcF)
Time frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
Plasma PK parameters of daridorexant: - AUC from 0 to 24 hours (AUC0-24)
Time frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
Plasma PK parameters of daridorexant: - Maximum plasma concentration (Cmax)
Time frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
Plasma PK parameters of daridorexant: - Time to reach Cmax (tmax)
Time frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
Plasma PK parameters of daridorexant: - T½
Time frame: Various time points (for up to 24 hours) on Day 1 and Day 2 of each period. The 4 periods will be separated by a wash-out period of 7-10 days. Total duration: up to 8 weeks.
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