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Completed

NCT Number: NCT03245229

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)

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Cepha s.r.o

Pilsen, 32300, Czechia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aprocitentan

Drug

Capsule for oral administration

Other names: ACT-132577

Rosuvastatin

Drug

Tablet for oral administration

Primary outcomes

  1. Maximum plasma concentration (Cmax) of rosuvastatin

    Time frame: Up to Day 29

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

  2. Time to reach Cmax (tmax) of rosuvastatin

    Time frame: Up to Day 29

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

  3. Terminal half-life (t1/2) of rosuvastatin

    Time frame: Up to Day 29

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

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

    Time frame: Up to Day 29

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

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

    Time frame: Up to Day 29

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

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

    Time frame: Up to Day 29

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

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to Day 29

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

  2. Changes from baseline in electrocardiogram (ECG) variables

    Time frame: Up to Day 29

    ECG variables are to be recorded at rest using a standard 12-lead ECG

  3. Changes from baseline in blood pressure

    Time frame: Up to Day 29

    Blood pressure (mmHg) measured using an automatic oscillometric device

  4. Changes from baseline in pulse rate

    Time frame: Up to Day 29

    Pulse rate (bpm) measured using an automatic oscillometric device

Sponsors and collaborators

Lead sponsor

Idorsia Pharmaceuticals Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 10, 2017
Registry last updated
Nov 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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