The primary purpose of this study is to investigate the fate of ACT-132577 in healthy subjects and in people with severe kidney disease
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
Capsule
CEPHA
Pilsen, Czechia
Maximum plasma concentration (Cmax) of ACT-132577
Cmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: From baseline to up to 16 days
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of ACT-132577
AUC(0-T) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: From baseline to up to 16 days
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
AUC(0-inf) of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: From baseline to up to 16 days
Time to reach Cmax (tmax) of ACT-132577
tmax of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: From baseline to up to 16 days
Terminal half-life [t(1/2)]
t1/2 of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: From baseline to up to 16 days
Incidence of treatment-emergent adverse events
The percentage of subjects with treatment-emergent adverse events will be reported
Time frame: From baseline to up to 16 days
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: From baseline to up to 16 days
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: From baseline to up to 16 days