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 Ltd.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Subjects

Interventions

AprocitentanDRUG

Capsule for oral administration

RosuvastatinDRUG

Tablet for oral administration

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 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; * 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.

Locations (1)

Cepha s.r.o

Pilsen, Czechia

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax) of rosuvastatin

Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time frame: Up to Day 29

Time to reach Cmax (tmax) of rosuvastatin

tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time frame: Up to Day 29

Terminal half-life (t1/2) of rosuvastatin

t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time frame: Up to Day 29

Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin

AUC(0-t) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles

Time frame: Up to Day 29

Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin

AUC(0-inf) of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profile

Time frame: Up to Day 29

Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577

Ctrough of ACT-132577 will be derived by non-compartmental analysis of the plasma concentration-time profile

Time frame: Up to Day 29

Secondary Outcomes

Number of participants with adverse events (AEs)

Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study

Data from ClinicalTrials.gov

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