Trial | NCT03245229  Report issue

Title

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)
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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
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 Started
Aug 10
2017
Primary Completion
Sep 18
2017
Study Completion
Sep 18
2017
Last Update
Nov 29
2022

Drug Aprocitentan

Capsule for oral administration

  • Other names: ACT-132577

Drug Rosuvastatin

Tablet for oral administration

Treatment A Experimental

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 B1 Experimental

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

Treatment B2 Experimental

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.

Criteria 

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.
No Results Posted