So far, ACT-541468 has been studied mainly in Caucasian subjects. The present study will bridge results obtained in Caucasian subjects to those in Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
40
Capsule
Matching placebo capsule
Centre for Human Drug Research
Leiden, Netherlands
Maximum plasma concentration (Cmax) of ACT-541468
The geometric mean Cmax values will be calculated based on pharmacokinetic (PK) blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Area under the plasma concentration-time curves during a dosing interval [AUC(0-24)] of ACT-541468
The geometric mean AUC(0-24) values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Time to reach Cmax (tmax) of ACT-541468
The median tmax values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Terminal half-life [t(1/2)] of ACT-541468
The geometric mean t(1/2) values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Area under the plasma concentration-time curves from time 0 to 8 h [AUC(0-8)]
The geometric mean AUC(0-8) values will be calculated based on PK blood sampling
Time frame: From Day1 pre-dose to 48 hours after the last dose on Day 5
Incidence of treatment-emergent adverse events
The percentage of subjects with treatment-emergent adverse events will be reported
Time frame: Up to Day 7 (end of study)
Incidence of adverse events leading to premature discontinuation of study treatment
The number of subjects who prematurely discontinued the study treatment due to an adverse event will be reported
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Time frame: Up to Day 5
Incidence of any clinical relevant findings in ECG variables
The number of subjects with any treatment-emergent electrocardiogram (ECG) abnormalities will be reported
Time frame: Up to Day 7 (end of study)