Clinical trial NCT03339752: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-11-13
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of ACT-541468 at steady-state on Cmax of single-dose rosuvastatin
timeFrame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
measure: Effect of ACT-541468 at steady-state on tmax of single-dose rosuvastatin
timeFrame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
measure: Effect of ACT-541468 at steady-state on AUC0-t of single-dose rosuvastatin
timeFrame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
measure: Effect of ACT-541468 at steady-state on AUC0-∞ of single-dose rosuvastatin
timeFrame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
measure: Effect of ACT-541468 at steady-state on t½ of single-dose rosuvastatin
timeFrame: During administration of rosuvastatin (Treatment A) and both rosuvastatin and ACT-541468 (Treatment B2); i.e. for about 2 weeks.
Secondary outcomes:
measure: Trough concentration (Ctrough) of ACT-541468
timeFrame: During ACT-541468 administration (Treatment B1 and B2); i.e. for about 1 week
measure: Change in vital signs
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
measure: Change in ECG variables
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
measure: Treatment-emergent (serious) adverse events
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
measure: Treatment-emergent ECG abnormalities
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
measure: Change in body weight
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
measure: Change in clinical laboratory tests
timeFrame: From Screening to EOS (for a maximum of up to 5 weeks)
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: Cepha s.r.o.
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clemens Mühlan
role: STUDY_DIRECTOR
References: