Healthy Subjects
Conditions
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
Interventions
DRUGRosuvastatin
10 mg tablet
DRUGACT-541468
25 mg hard capsule
Sponsors
Idorsia Pharmaceuticals Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 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 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 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 |
| 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 |
| Treatment-emergent ECG abnormalities | From Screening to EOS (for a maximum of up to 5 weeks) | Treatment-emergent ECG abnormalities during each treatment |
Countries
Czechia
Outcome results
None listed