A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-541468 Can Affect the Fate in the Body (Amount and Time of Presence in the Blood) of Rosuvastatin
- Registration Number
- NCT03339752
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
A study in healthy male subjects to investigate whether administration of ACT-541468 can affect the fate in the body (amount and time of presence in the blood) of rosuvastatin
- 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.
- Known allergic reactions or hypersensitivity to ACT-541468, 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-541468;
- 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
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment B2 Rosuvastatin Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12 Treatment A Rosuvastatin Rosuvastatin Day 1 Treatment B1 ACT-541468 ACT-541468 Day 5 to Day 7 Treatment B2 ACT-541468 Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12
- Primary Outcome Measures
Name Time Method Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks. Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
- Secondary Outcome Measures
Name Time Method Treatment-emergent (serious) adverse events From Screening to EOS (for a maximum of up to 5 weeks) Treatment-emergent AEs and SAEs during each treatment
Trough concentration (Ctrough) of ACT-541468 During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week Trough concentration (Ctrough) of ACT-541468
Change in vital signs From Screening to EOS (for a maximum of up to 5 weeks) Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate)
Change in body weight From Screening to EOS (for a maximum of up to 5 weeks) Change from baseline to each time point of measurement during each treatment in body weight
Treatment-emergent ECG abnormalities From Screening to EOS (for a maximum of up to 5 weeks) Treatment-emergent ECG abnormalities during each treatment
Change in clinical laboratory tests From Screening to EOS (for a maximum of up to 5 weeks) Change from baseline to each time point of measurement during each treatment in clinical laboratory tests
Change in ECG variables From Screening to EOS (for a maximum of up to 5 weeks) Change from baseline to each time point of measurement during each treatment in ECG variables
Trial Locations
- Locations (1)
Cepha s.r.o.
🇨🇿Pilsen, Czechia