NCT04821063

Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval

A Randomized, Partially Double-Blind, Four-Period, Four-Treatment, Crossover Study Investigating the Placebo-Corrected Effects of a Therapeutic Dose (100 mg) and a Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval in Healthy Male and Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the effect of a therapeutic dose and a supratherapeutic dose of ITF2357 on the QT/QTc interval.

Conditions

• Duchenne and Becker Muscular Dystrophy
• Polycytemia Vera

Interventions

Type	Name	Description
DRUG	ITF2357 10 mg/mL	Dose: 100 mg (administered as 10 mL); Dosage form: suspension; Route of administration: oral
DRUG	ITF2357 10 mg/mL	Dose: 300 mg (administered as 30 mL); Dosage form: suspension; Route of administration: oral
DRUG	Placebo	Dose: 20 mL; Dosage form: suspension; Route of administration: oral
DRUG	Moxifloxacin Hydrochloride	Dose: 400 mg; Dosage form: tablet; Route of administration: oral
DRUG	Placebo	Dose: 30 mL; Dosage form: suspension; Route of administration: oral

Timeline

• Start date: 2021-04-13
• Primary completion: 2021-06-18
• Completion: 2021-06-18
• First posted: 2021-03-29
• Last updated: 2024-01-11
• Results posted: 2024-01-11

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study