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)

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Rosuvastatin; Drug: Aprocitentan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03245229

AC-080-106

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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;
• Hemoglobin ≥ 135 g/L at screening.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Treatment A

Experimental group

Description:

In the morning of Day 1, a single dose of 10 mg rosuvastatin will be administered in the fasted state followed by an observation period of 96 h

Treatment:

Drug: Rosuvastatin

Treatment B1

Experimental group

Description:

25 mg ACT-132577 will be administered o.d. from Day 5 to Day 12

Treatment:

Drug: Aprocitentan

Treatment B2

Experimental group

Description:

In the morning of Day 13, a single dose of 10 mg rosuvastatin will be administered in the fasted state, concomitantly with 25 mg ACT-132577, followed by an observation period of 120 h. Doses of 25 mg ACT-132577 will be administered o.d. from Day 14 to Day 17.

Treatment:

Drug: Aprocitentan

Drug: Rosuvastatin