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Thorough QT Study of Intravenous Amisulpride

NCT02661594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2018-11-29

Study results available
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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.

Conditions

  • Healthy

Interventions

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

Sponsors & Collaborators

  • Acacia Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Gabriel Fox, MB BChir · Acacia Pharma Ltd

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-03-31
Completion
2014-03-31

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02661594 on ClinicalTrials.gov