Ignite Creation Date:
2024-05-06 @ 2:28 AM
Last Modification Date:
2024-10-26 @ 11:18 AM
Study NCT ID:
NCT02050802
Status:
COMPLETED
Last Update Posted:
2014-01-31
First Post:
2014-01-29
Brief Title:
Study to Assess the Effect of Macitentan on the Electrocardiogram ECG in Healthy Male and Female Subjects
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Four-way Crossover Phase 1 Study Including an Open-label Positive Control Moxifloxacin to Assess the Effect of Repeated Daily Doses of 10 mg and 30 mg Macitentan on the QTQTc Interval of the ECG in Healthy Male and Female Subjects
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None