Status:
COMPLETED
A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)
Lead Sponsor:
Idorsia Pharmaceuticals Ltd.
Conditions:
Healthy Subjects
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects
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;
- Hemoglobin ≥ 135 g/L at screening.
Exclusion
- Known allergic reactions or hypersensitivity to ACT-132577, 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-132577;
- 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 :
August 10 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 18 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03245229
Start Date
August 10 2017
End Date
September 18 2017
Last Update
November 29 2022
Active Locations (1)
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1
Cepha s.r.o
Pilsen, Czechia, 32300