Healthy Subjects
Conditions
Brief summary
This clinical study will be conducted to evaluate the effect of ACT-132577 on fluid homeostasis in healthy subjects.
Interventions
DRUGAprocitentan
Formulated in capsules in 2 different strengths; 2 capsules per day
OTHERPlacebo
Matching active drug
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent * Healthy on the basis of medical history, physical examination, cardiovascular assessments and hematology, clinical chemistry, and urinalysis tests * Body mass index between 20.0 and 25.0 kg/m2 (inclusive) at screening
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body weight | from Day 1 to Day 9 | Change from baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment-emergent Adverse Events | From Day 1 up to End-of-Study (i.e. for at least 25 days) | Number of subjects with Adverse Events |
| Treatment-emergent Serious Adverse Events | From Screening (Day -3) up to Follow-up (i.e. for at least 49 days) | Number of subjects with Serious Adverse Events |
| Glomerular filtration rate (GFR) | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 | Change from baseline to each scheduled timepoint |
| Fractional sodium excretion in 24 h urine samples [mmol per day] | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 | Fractional excretion will be calculated as the clearance of sodium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint |
| Fractional lithium excretion in 24 h urine samples [mmol per day] | At 0 h of Day 1, at 1 h, 2 h, 4 h, 6 h and 10 h of Day 1 & Day 9 | Fractional excretion will be calculated as the clearance of lithium divided by the clearance of creatinine. Change from baseline to each scheduled timepoint |
Countries
Switzerland
Outcome results
None listed