PRA Health Sciences
Groningen, Netherlands
NCT Number: NCT03100591
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
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Notify Me45 year–65 year
Male
Interventional
Phase 1
Groningen, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg
Other names: Aprocitentan
Time frame: From study treatment administration up to day 15
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 32
Collection of any adverse event at each dose level
Time frame: From study treatment administration up to day 15
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
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
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
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
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
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
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
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
Idorsia Pharmaceuticals Ltd.
Industry
Single-center, Open-label Study With 14C-radiolabeled ACT-132577 to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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