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

Study Overview
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Brief Summary
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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

Official Title
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A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-541468 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: ACT-541468


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Rosuvastatin Day 1 | Drug: Rosuvastatin<br>* 10 mg tablet<br>|
| Experimental: Treatment B1<br>ACT-541468 Day 5 to Day 7 | Drug: ACT-541468<br>* 25 mg hard capsule<br>|
| Other: Treatment B2<br>Rosuvastatin Day 8; ACT-541468 Day 8 to Day 12 | Drug: Rosuvastatin<br>* 10 mg tablet<br>Drug: ACT-541468<br>* 25 mg hard capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of ACT-541468 at steady-state on Cmax 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 tmax 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 AUC0-t 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-∞ 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 t½ 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trough concentration (Ctrough) of ACT-541468 | Trough concentration (Ctrough) of ACT-541468 | During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week | 
| Change in vital signs | Change from baseline to each time point of measurement during each treatment in vital signs (supine BP and pulse rate) | From Screening to EOS (for a maximum of up to 5 weeks) | 
| Change in ECG variables | Change from baseline to each time point of measurement during each treatment in ECG variables | From Screening to EOS (for a maximum of up to 5 weeks) | 
| Treatment-emergent (serious) adverse events | Treatment-emergent AEs and SAEs during each treatment | From Screening to EOS (for a maximum of up to 5 weeks) | 
| Treatment-emergent ECG abnormalities | Treatment-emergent ECG abnormalities during each treatment | From Screening to EOS (for a maximum of up to 5 weeks) | 
| Change in body weight | Change from baseline to each time point of measurement during each treatment in body weight | From Screening to EOS (for a maximum of up to 5 weeks) | 
| Change in clinical laboratory tests | Change from baseline to each time point of measurement during each treatment in clinical laboratory tests | From Screening to EOS (for a maximum of up to 5 weeks) |