Healthy Subjects
Conditions
Brief summary
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
Interventions
DRUGAprocitentan
Capsule for oral administration
DRUGRosuvastatin
Tablet for oral administration
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed informed consent in the local language prior to any study mandated procedure; * Healthy male subjects aged 18 to 45 years (inclusive) at screening; * Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening; * Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests; * Hemoglobin ≥ 135 g/L at screening.
Exclusion criteria
* Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients; * Any contraindication for rosuvastatin treatment; * History or clinical evidence of myopathy; * Asian or Indian-Asian ethnicity; * Known hypersensitivity or allergy to natural rubber latex; * Previous exposure to ACT-132577; * Treatment with rosuvastatin within 3 months prior to screening; * 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 |
|---|---|---|
| Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577 | Up to Day 29 | Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile |
| Time to reach Cmax (tmax) of rosuvastatin | Up to Day 29 | tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Terminal half-life (t1/2) of rosuvastatin | Up to Day 29 | t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin | Up to Day 29 | AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles |
| Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin | Up to Day 29 | AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile |
| Maximum plasma concentration (Cmax) of rosuvastatin | Up to Day 29 | Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in electrocardiogram (ECG) variables | Up to Day 29 | ECG variables are to be recorded at rest using a standard 12-lead ECG |
| Changes from baseline in blood pressure | Up to Day 29 | Blood pressure (mmHg) measured using an automatic oscillometric device |
| Changes from baseline in pulse rate | Up to Day 29 | Pulse rate (bpm) measured using an automatic oscillometric device |
| Number of participants with adverse events (AEs) | Up to Day 29 | Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study |
Countries
Czechia
Outcome results
None listed