NCT02661594

Thorough QT Study of Intravenous Amisulpride

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Acacia Pharma Ltd · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	APD421 5 mg	Therapeutic dose of amisulpride
DRUG	APD421 40 mg	Supra-therapeutic dose of amisulpride
DRUG	Moxifloxacin	Positive control for assay sensitivity
DRUG	Placebo	Placebo comparator to establish baseline for calculating change in QTcF

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2016-01-22
• Last updated: 2018-11-29
• Results posted: 2017-11-30