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The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h |
|
| Treatment B1 | Experimental | 25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12 |
|
| Treatment B2 | Experimental | In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h. Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprocitentan | Drug | Capsule for oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of rosuvastatin | Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 29 |
| Time to reach Cmax (tmax) of rosuvastatin | tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 29 |
| Terminal half-life (t1/2) of rosuvastatin | t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 29 |
| Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin | AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles | Up to Day 29 |
| Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin | AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile | Up to Day 29 |
| Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577 | Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile | Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study | Up to Day 29 |
| Changes from baseline in electrocardiogram (ECG) variables |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cepha s.r.o | Pilsen | 32300 | Czechia |
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| Rosuvastatin | Drug | Tablet for oral administration |
|
ECG variables are to be recorded at rest using a standard 12-lead ECG
| Up to Day 29 |
| Changes from baseline in blood pressure | Blood pressure (mmHg) measured using an automatic oscillometric device | Up to Day 29 |
| Changes from baseline in pulse rate | Pulse rate (bpm) measured using an automatic oscillometric device | Up to Day 29 |
| ID | Term |
|---|---|
| C572762 | aprocitentan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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