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A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants

NCT04211272 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2025-03-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of macitentan at steady state on the pharmacokinetic (PK) of a single dose of riociguat and sildenafil (Part A); and rosuvastatin (Part B) when co-administered to healthy male participants under fasted conditions.

Conditions

  • Healthy

Interventions

DRUG

Macitentan

Macitentan will be administrated as film-coated tablet in Part A and Part B.

DRUG

Sildenafil

Sildenafil will be administrated as film-coated tablet in Part A.

DRUG

Riociguat

Riociguat will be administrated as film-coated tablet in Part A.

DRUG

Rosuvastatin

Rosuvastatin will be administrated as film-coated tablet in Part B.

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Actelion Clinical Trial · Actelion

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-01-14
Primary Completion
2021-04-19
Completion
2021-04-19

Countries

  • Belgium

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 NCT04211272 on ClinicalTrials.gov