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)

Healthy Subjects Clinical Trial

Official title:

A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03245229
• Other study ID #: AC-080-106
• Status: Completed
• Phase: Phase 1
• Start date: August 10, 2017
• Est. completion date: September 18, 2017

Study information

• Verified date: November 2022
• Source: Idorsia Pharmaceuticals Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Aprocitentan
Capsule for oral administration
• Rosuvastatin
Tablet for oral administration

Locations

Country	Name	City	State
Czechia	Cepha s.r.o	Plzen

Sponsors (1)

Lead Sponsor	Collaborator
Idorsia Pharmaceuticals Ltd.

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of rosuvastatin	Cmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles	Up to Day 29
Primary	Time to reach Cmax (tmax) of rosuvastatin	tmax of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles	Up to Day 29
Primary	Terminal half-life (t1/2) of rosuvastatin	t1/2 of rosuvastatin will be derived by non-compartmental analysis of the plasma concentration-time profiles	Up to Day 29
Primary	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	Up to Day 29
Primary	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	Up to Day 29
Primary	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	Up to Day 29
Secondary	Number of participants with adverse events (AEs)	Treatment emergent adverse events and treatment emergent serious adverse events will be evaluated throughout the study	Up to Day 29
Secondary	Changes from baseline in electrocardiogram (ECG) variables	ECG variables are to be recorded at rest using a standard 12-lead ECG	Up to Day 29
Secondary	Changes from baseline in blood pressure	Blood pressure (mmHg) measured using an automatic oscillometric device	Up to Day 29
Secondary	Changes from baseline in pulse rate	Pulse rate (bpm) measured using an automatic oscillometric device	Up to Day 29