Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-03-06 @ 2:55 PM
Study NCT ID:
NCT02661594
Status:
COMPLETED
Last Update Posted:
2018-11-29
First Post:
2016-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Thorough QT Study of Intravenous Amisulpride
Sponsor:
Acacia Pharma Ltd
Organization:
Study Overview
Official Title:
A Randomised, Double-blind, Four-period Crossover Study to Investigate the Effect of Intravenous APD421 on Cardiac Conduction as Compared to Placebo and Moxifloxacin in Healthy Adult Subjects
Status:
COMPLETED
Status Verified Date:
2018-11
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:
Randomised, single-dose, crossover, placebo-controlled study to see if intravenous amisulpride has any effect on the heart rhythm, in particular the QT interval, in healthy adult volunteers.
Detailed Description:
Phase 1, randomised, single-dose, period-balanced, crossover, placebo- controlled study to assess the effects of iv doses of amisulpride on the QT interval, corrected for heart rate by Fridericia's formula (QTcF), in healthy male and female subjects of Caucasian and Japanese ethnicity aged 20-45 years.
Study Oversight
Has Oversight DMC:
False
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?: