Clinical study in healthy adult subjects to compare the adult tablet of selexipag with the tablet developed for children.
Healthy male adults receive a single dose of selexipag (200 µg) but using a different tablet strength (4 film-coated pediatric tablets of 50 µg versus one film-coated tablet of 200 µg selexipag) during each of the two study periods. There is a washout of 7-9 days between the two study treatment administrations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
20
One selexipag film-coated tablet of 200 µg
Four selexipag film-coated tablets of 50 µg
Area under plasma concentration-time curve [AUC(0-inf)] of selexipag and ACT-333679
AUC(0-inf) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to the extrapolated infinite time
Time frame: From predose until 72 hours postdose for each treatment period
Maximum plasma concentration (Cmax) of selexipag and ACT-333679
Cmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679
Time frame: From predose until 72 hours postdose for each treatment period
Time to reach Cmax (tmax) of selexipag and ACT-333679
tmax is directly derived from the individual plasma concentration time curves for selexipag and its metabolite ACT-333679
Time frame: From predose until 72 hours postdose for each treatment period
Terminal half-life (t½) of selexipag and ACT-333679
The period of time required for the concentration levels of selexipag or its metabolite (ACT-333679) to be reduced by one-half
Time frame: From predose until 72 hours postdose for each treatment period
Area under plasma concentration-time curve [AUC(0-t)] of selexipag and ACT-333679
AUC(0-t) is the area under plasma concentration-time curves for selexipag and its metabolite (ACT-333679), calculated from zero to time t of the last measured concentration above the limit of quantification
Time frame: From predose until 72 hours postdose for each treatment period
Incidence of treatment-emergent adverse events and serious adverse events
A treatment-emergent AE is any AE temporally associated with the use of a study treatment, whether or not considered related to the study treatment, including any abnormalities in ECG parameters, vital signs or laboratory tests
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Time frame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)
Incidence of safety events of interest
Events of interest include any abnormalities in ECG, vital signs or laboratory test results
Time frame: From first administration of selexipag (Day 1 Period 1) to end of study (Day 4, Period 2)