NCT03516630

Effects of Three Single Oral Doses of Trazodone on the QTc Interval Duration in Healthy Volunteers

Single Centre, Single Dose, Randomised, Negative and Positive-controlled, Double-blind Trazodone vs. Negative Control (Placebo), Open-label vs. Positive Control (Moxifloxacin), 5-way Cross-over QT/QTc Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The present study has been designed to evaluate the effect of three doses of trazodone (20, 60 and 140 mg), in comparison to placebo, on the QT/QTc interval of healthy volunteers. Trazodone oral drops 6% formulation has been selected in order to evaluate the three doses using the same formulation, because the lowest available strength for the tablet formulations is 50 mg. According to the E14 guideline on the evaluation of QT/QTc interval prolongation and proarrhythmic potential of antiarrhytmic drugs, a negative control (placebo) and a positive control (moxifloxacin) will also be assessed.

Detailed description

Twenty (20) healthy volunteers (about 50% males and 50% females) will be randomised. Primary end-point: * Evaluation of the relationship between the plasma concentration of trazodone (free base) and the change from baseline in QTc, placebo-adjusted and corrected for HR based on the Fridericia correction method (QTcF) method (∆∆QTcF). * Trazodone can be declared to have no influence on QTc if the null hypothesis, that the upper bound of the two-sided 90% CI of the predicted mean placebo corrected change from baseline for QTcF is greater than 10 msec at the observed mean Cmax for the therapeutic dose of trazodone, can be rejected.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Trazodone 20 mg	Oral drops
DRUG	Trazodone 60 mg	Oral drops
DRUG	Trazodone 140 mg	Oral drops
DRUG	Placebo	Oral drops
DRUG	Moxifloxacin 400mg	Tablet

Timeline

• Start date: 2017-03-20
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2018-05-04
• Last updated: 2020-07-31

Locations

1 site across 1 country: Switzerland