Clinical Trials Directory

Trials / Completed

CompletedNCT03657446

A Study in Healthy Subjects to Investigate Whether Administration of Clazosentan Can Affect Normal Heart Function

Randomized, Double-blind (for Clazosentan), Placebo- and Moxifloxacincontrolled, 3-way Cross-over Phase 1 Study to Assess the Effect of Two Intravenous Doses of Clazosentan on the QTc Interval Duration in Healthy Subjects

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
36 (actual)
Sponsor
Idorsia Pharmaceuticals Ltd. · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

Summary

The study will investigate whether administration of clazosentan can affect normal heart function in healthy subjects

Conditions

Interventions

TypeNameDescription
DRUGClazosentanContinuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
DRUGPlaceboMatching placebo infusion
DRUGMoxifloxacinFilm-coated tablet containing 400 mg moxifloxacin

Timeline

Start date
2018-09-18
Primary completion
2018-10-26
Completion
2018-10-26
First posted
2018-09-05
Last updated
2018-11-20

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03657446. Inclusion in this directory is not an endorsement.