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

Idorsia Pharmaceuticals Ltd.20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

RosuvastatinDRUG

10 mg tablet

ACT-541468DRUG

25 mg hard capsule

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Cepha s.r.o.

Pilsen, Czechia