A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)
- Registration Number
- NCT03245229
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment A Rosuvastatin 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 B2 Rosuvastatin 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. Treatment B1 Aprocitentan 25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12 Treatment B2 Aprocitentan 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.
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method Changes from baseline in blood pressure Up to Day 29 Blood pressure (mmHg) 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
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 pulse rate Up to Day 29 Pulse rate (bpm) measured using an automatic oscillometric device
Trial Locations
- Locations (1)
Cepha s.r.o
🇨🇿Plzen, Czechia