Conditions: Healthy
Keywords: TQT amisulpride volunteer ECG
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 40
Healthy volunteers: yes

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.

Arms:
arm 1: A: APD421 5 mg followed by B: APD421 40 mg; C: Moxifloxacin 400 mg; D: Placebo. arm 2: B: APD421 40 mg; D: Placebo. A: APD421 5 mg C: Moxifloxacin 400 mg; arm 3: C: Moxifloxacin 400 mg A: APD421 5 mg D: Placebo B: APD421 40 mg arm 4: D: Placebo C: Moxifloxacin 400 mg B: APD421 40 mg A: APD421 5 mg

Interventions: intervention 1: APD421 5 mg intervention 2: APD421 40 mg intervention 3: Moxifloxacin intervention 4: Placebo
Intervention descriptions: intervention 1: Therapeutic dose of amisulpride intervention 2: Supra-therapeutic dose of amisulpride intervention 3: Positive control for assay sensitivity intervention 4: Placebo comparator to establish baseline for calculating change in QTcF

Protocol document: