The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
6
Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie \[μCi\]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg
PRA Health Sciences
Groningen, Netherlands
Cumulative excretion of radioactivity in urine and feces
14C-radioactivity will be measured daily in urine and feces samples for determination of total radioactivity recovery
Time frame: From study treatment administration up to day 15
Number of subjects with treatment-emergent adverse events and serious adverse events
Collection of any adverse event at each dose level
Time frame: From study treatment administration up to day 32
Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Time to reach Cmax (tmax) of 14C-radiolabeled ACT-132577
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Terminal half-life (t1/2) of 14C-radiolabeled ACT-132577
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) of 14C-radiolabeled ACT-132577
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Time frame: From study treatment administration up to day 15
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Maximum plasma concentration (Cmax) of ACT-132577 and its metabolites
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Time to reach Cmax (tmax) of ACT-132577 and its metabolites
tmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Terminal half-life (t1/2) of ACT-132577 and its metabolites
t1/2 is calculated from the terminal rate constant obtained from the plasma concentrations-time curves of ACT-132577 and its metabolites
Time frame: From study treatment administration up to day 15
Area under the plasma concentration-time curve (AUC) ACT-132577 and its metabolites
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Time frame: From study treatment administration up to day 15