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

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.

Timeline

Start

2017-03-20

Primary completion

2017-05-01

Completion

2017-05-01

Outcome

Mixed primary results

paper The concentration-QTc relationship assessed on placebo-adjusted change from baseline for Fridericia-corrected QT (ΔΔQTcF) was the primary end point. PMID 32488885 ↗

paper The upper bound of the 90%CI exceeded 10 ms for the 60- and the 140-mg doses. PMID 32488885 ↗

paper with no QTc prolongation observed with the 20-mg dose PMID 32488885 ↗

Publications

• Tellone V, Rosignoli MT, Picollo R, Dragone P, Del Vecchio A, Comandini A, Radicioni M, Leuratti C, Calisti F. Effect of 3 Single Doses of Trazodone on QTc Interval in Healthy Subjects. J Clin Pharmacol. 2020 Nov;60(11):1483-1495. doi: 10.1002/jcph.1640. Epub 2020 Jun 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Moxifloxacin	Small molecule	400 mg	Oral
Subject	Trazodone	Small molecule	20 mg	Oral
Subject	Trazodone	Small molecule	60 mg	Oral
Subject	Trazodone	Small molecule	140 mg	Oral

Indications

No indication recorded.