NCT04821063View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

April 13, 2021

Primary Completion Date

June 18, 2021

Study Completion Date

June 18, 2021

Conditions
Duchenne and Becker Muscular DystrophyPolycytemia 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

Trial Locations (1)

G1P 0A2

Québec, Québec

Sponsors

Lead Sponsor

Italfarmaco
All Listed Sponsors
lead

Italfarmaco

INDUSTRY

NCT04821063 - Placebo-Corrected Effects of Therapeutic Dose (100 mg) and Supratherapeutic Dose (300 mg) of ITF2357 (Givinostat) and Moxifloxacin on QT/QTC Interval | Biotech Hunter | Biotech Hunter