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Clinical Study to Investigate the Effect of Macitentan on the Concentrations of Rosuvastatin in the Blood of Healthy Male Subjects

NCT03359291 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-22

No results posted yet for this study

Summary

The aim of this Phase 1 trial is to study a potential drug-drug interaction between macitentan and rosuvastatin, a model substrate of various transporter proteins (e.g. in the gut).

Conditions

  • Healthy Subjects

Interventions

DRUG

Rosuvastatin

Single oral dose of 10 mg rosuvastatin (film-coated tablet) on Day 1 and Day 10

DRUG

Macitentan

Single oral dose of 30 mg macitentan (film-coated tablet) on Day 5 and 10 mg macitentan administered orally from Day 6 to Day 16

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Shirin Bruderer, PhD · Actelion

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2017-12-04
Completion
2017-12-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03359291 on ClinicalTrials.gov