Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-132577 | Experimental | 3 different dose levels |
|
| Placebo | Placebo Comparator | Matching active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprocitentan | Drug | Formulated in capsules in 2 different strengths; 2 capsules per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Change from baseline | from Day 1 to Day 9 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-emergent Adverse Events | Number of subjects with Adverse Events | From Day 1 up to End-of-Study (i.e. for at least 25 days) |
| Treatment-emergent Serious Adverse Events | Number of subjects with Serious Adverse Events |
Inclusion Criteria:
Exclusion Criteria:
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site Lausanne | Lausanne | 1011 | Switzerland |
Not provided
| ID | Term |
|---|---|
| C572762 | aprocitentan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Matching active drug |
|
| From Screening (Day -3) up to Follow-up (i.e. for at least 49 days) |
| Glomerular filtration rate (GFR) | Change from baseline to each scheduled timepoint | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 |
| Fractional sodium excretion in 24 h urine samples [mmol per day] | Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 |
| Fractional lithium excretion in 24 h urine samples [mmol per day] | Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 |