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

NCT04821063 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2024-01-11

Study results available
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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

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

Sponsors & Collaborators

  • Italfarmaco

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-13
Primary Completion
2021-06-18
Completion
2021-06-18
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04821063 on ClinicalTrials.gov