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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 14C-radiolabelled ACT-132577 | Experimental | On Day 1, subjects will receive a single oral dose of 25 mg 14C-radiolabeled ACT-132577, administered as an oral formulation in the fasted state |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14C-radiolabeled ACT-132577 | Drug | Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From study treatment administration up to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with treatment-emergent adverse events and serious adverse events | Collection of any adverse event at each dose level | From study treatment administration up to day 32 |
| Maximum plasma concentration (Cmax) of 14C-radiolabeled ACT-132577 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Groningen | Netherlands |
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| ID | Term |
|---|---|
| C572762 | aprocitentan |
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|
Cmax is directly derived from the observed plasma concentrations of ACT-132577 and its metabolites |
| 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 | 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 | 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 | From study treatment administration up to day 15 |
| 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 | 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 | 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 | 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 | From study treatment administration up to day 15 |