CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
ITF2357 10 mg/mL +4 moredrug
Likely dose
ITF2357 10 mg/mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04821063
NCT04821063Phase 1Completed
CompareCT.gov

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

Italfarmaco·interventional·Posted Mar 29, 2021·Updated Jan 11, 2024

In Brief

A Phase 1 clinical trial evaluating ITF2357 10 mg/mL, Placebo, and 1 other intervention for Duchenne and Becker Muscular Dystrophy and Polycytemia Vera. Completed, enrolled 31 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDuchenne and Becker Muscular Dystrophy, Polycytemia Vera
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 29, 2021
Enrollment StartApr 13, 2021
Primary CompletionJun 18, 2021
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 5.3 years ago

Interventions

ITF2357 10 mg/mLdrug

Dose: 100 mg (administered as 10 mL); Dosage form: suspension; Route of administration: oral

ITF2357 10 mg/mLdrug

Dose: 300 mg (administered as 30 mL); Dosage form: suspension; Route of administration: oral

Placebodrug

Dose: 20 mL; Dosage form: suspension; Route of administration: oral

Moxifloxacin Hydrochloridedrug

Dose: 400 mg; Dosage form: tablet; Route of administration: oral

Placebodrug

Dose: 30 mL; Dosage form: suspension; Route of administration: oral