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Study to Assess the Effect of Macitentan on the Electrocardiogram (ECG) in Healthy Male and Female Subjects

NCT02050802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-02-03

No results posted yet for this study

Summary

The study is intended to demonstrate that macitentan does not have an effect on cardiac repolarization exceeding the threshold of regulatory concern after repeated administration of daily oral doses of 10 and 30 mg to healthy male and female subjects.

Conditions

  • Healthy

Interventions

DRUG

Moxifloxacin 400 mg

DRUG

Macitentan 10 mg

DRUG

Macitentan 30 mg

OTHER

Placebo

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Nicolas Lindegger, PhD · Actelion

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

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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 NCT02050802 on ClinicalTrials.gov