CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
APD421 5 mg +3 moredrug
Likely dose
APD421 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02661594
NCT02661594Phase 1Completed
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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

Acacia Pharma Ltd·interventional·Posted Jan 22, 2016·Updated Nov 29, 2018

In Brief

A Phase 1 clinical trial evaluating APD421 5 mg, APD421 40 mg, and 2 other interventions for Healthy. Completed, enrolled 40 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 22, 2016
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 10.4 years ago

Interventions

APD421 5 mgdrug

Therapeutic dose of amisulpride

APD421 40 mgdrug

Supra-therapeutic dose of amisulpride

Moxifloxacindrug

Positive control for assay sensitivity

Placebodrug

Placebo comparator to establish baseline for calculating change in QTcF