Status:
COMPLETED
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
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy Subjects
Eligibility:
MALE
18-64 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03339752
Start Date
October 30 2017
End Date
December 2 2017
Last Update
December 11 2017
Active Locations (1)
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1
Cepha s.r.o.
Pilsen, Czechia, 32300