NCT04821063 is a Phase 1 clinical trial of ITF2357 10 mg/mL in Duchenne and Becker Muscular Dystrophy, sponsored by Italfarmaco.

Who is sponsoring NCT04821063?

NCT04821063 is sponsored by Italfarmaco.

What drugs are being tested in NCT04821063?

Interventions in NCT04821063: ITF2357 10 mg/mL, ITF2357 10 mg/mL, Placebo, Moxifloxacin Hydrochloride, Placebo.

What condition does NCT04821063 study?

NCT04821063 studies Duchenne and Becker Muscular Dystrophy, Polycytemia Vera.

Is NCT04821063 still recruiting?

NCT04821063 is currently completed. Last updated 11 January 2024.

Are results published for NCT04821063?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-01-11 · How we verify

NCT04821063

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 11 January 2024

What this trial tests

Phase 1 trial testing ITF2357 10 mg/mL in Duchenne and Becker Muscular Dystrophy in 31 participants. Completed in 18 June 2021.

Timeline

13 April 2021

Primary endpoint
18 June 2021

18 June 2021

Quick facts

Lead sponsor	Italfarmaco
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	31
Start date	13 April 2021
Primary completion	18 June 2021
Estimated completion	18 June 2021
Sites	1 location across Canada

Drugs / interventions tested

ITF2357 10 mg/mL — full drug profile →
ITF2357 10 mg/mL — full drug profile →
Placebo
Moxifloxacin Hydrochloride — full drug profile →
Placebo

Conditions studied

Duchenne and Becker Muscular Dystrophy — all drugs for Duchenne and Becker Muscular Dystrophy →
Polycytemia Vera — all drugs for Polycytemia Vera →

Sponsor

Italfarmaco — full company profile →

Who can join

Adults 18 to 55, any sex, with Duchenne and Becker Muscular Dystrophy or Polycytemia Vera. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Placebo-corrected Change From Baseline in Fridericia's Corrected QT Interval (QTcF) Primary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

The cardio-dynamic assessment was performed through 12-lead electrocardiogram (ECG) extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The QT interval is the time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole. QT interval was corrected for heart rate using QTcF. Placebo-corrected change from baseline in QTcF (ΔΔQTcF) was calculated based on model-predicted effect.

0.5 hours post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1.0	± 1.06
Supratherapeutic Dose: ITF2357 300 mg	0.5	± 1.04
Moxifloxacin	10.2	± 1.05

1 hours post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.3	± 1.01
Supratherapeutic Dose: ITF2357 300 mg	0.8	± 0.99
Moxifloxacin	13.1	± 1.00

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1.0	± 0.99
Supratherapeutic Dose: ITF2357 300 mg	2.7	± 0.97
Moxifloxacin	12.3	± 0.98

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.1	± 1.00
Supratherapeutic Dose: ITF2357 300 mg	4.3	± 0.98
Moxifloxacin	14.0	± 0.99

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.6	± 1.17
Supratherapeutic Dose: ITF2357 300 mg	6.1	± 1.15
Moxifloxacin	14.8	± 1.16

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.3	± 1.06
Supratherapeutic Dose: ITF2357 300 mg	6.6	± 1.04
Moxifloxacin	14.0	± 1.05

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.8	± 1.14
Supratherapeutic Dose: ITF2357 300 mg	9.1	± 1.12
Moxifloxacin	12.8	± 1.13

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	4.0	± 1.13
Supratherapeutic Dose: ITF2357 300 mg	10.4	± 1.11
Moxifloxacin	11.9	± 1.12

Change From Baseline in QTcF Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

The cardio-dynamic assessment was performed through 12-lead ECGs extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. QT interval was corrected for heart rate using Fridericia's correction (QTcF).

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.7	± 0.88
Supratherapeutic Dose: ITF2357 300 mg	-1.3	± 0.86
Moxifloxacin	8.5	± 0.87
Placebo	-1.8	± 0.86

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.3	± 0.85
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.83
Moxifloxacin	12.5	± 0.84
Placebo	-0.6	± 0.83

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.8	± 0.84
Supratherapeutic Dose: ITF2357 300 mg	2.5	± 0.81
Moxifloxacin	12.1	± 0.82
Placebo	-0.2	± 0.81

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1.3	± 0.85
Supratherapeutic Dose: ITF2357 300 mg	3.6	± 0.82
Moxifloxacin	13.2	± 0.83
Placebo	-0.8	± 0.82

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.1	± 0.95
Supratherapeutic Dose: ITF2357 300 mg	5.5	± 0.93
Moxifloxacin	14.2	± 0.94
Placebo	-0.5	± 0.93

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.9	± 0.88
Supratherapeutic Dose: ITF2357 300 mg	7.1	± 0.86
Moxifloxacin	14.5	± 0.87
Placebo	0.5	± 0.86

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	4.5	± 0.93
Supratherapeutic Dose: ITF2357 300 mg	10.7	± 0.91
Moxifloxacin	14.4	± 0.92
Placebo	1.6	± 0.91

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	6.0	± 0.93
Supratherapeutic Dose: ITF2357 300 mg	12.4	± 0.90
Moxifloxacin	13.9	± 0.91
Placebo	2.0	± 0.90

Change From Baseline in PR Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

The cardio-dynamic assessment was performed through 12-lead ECGs extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. The PR interval is the time from the onset of the P-wave to the start of the next QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.0	± 0.83
Supratherapeutic Dose: ITF2357 300 mg	-0.7	± 0.81
Moxifloxacin	0.1	± 0.82
Placebo	0.2	± 0.81

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.4	± 1.04
Supratherapeutic Dose: ITF2357 300 mg	0.7	± 1.01
Moxifloxacin	-0.3	± 1.02
Placebo	2.3	± 1.01

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-1.4	± 1.03
Supratherapeutic Dose: ITF2357 300 mg	-0.3	± 1.00
Moxifloxacin	-0.4	± 1.01
Placebo	1.1	± 1.00

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.4	± 1.04
Supratherapeutic Dose: ITF2357 300 mg	-1.3	± 1.01
Moxifloxacin	-0.1	± 1.02
Placebo	1.6	± 1.01

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.4	± 1.03
Supratherapeutic Dose: ITF2357 300 mg	-2.3	± 1.00
Moxifloxacin	0.8	± 1.00
Placebo	-1.9	± 1.01

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-1.3	± 1.03
Supratherapeutic Dose: ITF2357 300 mg	-1.6	± 1.00
Moxifloxacin	-1.3	± 1.01
Placebo	0.2	± 1.00

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.6	± 0.97
Supratherapeutic Dose: ITF2357 300 mg	-2.8	± 0.94
Moxifloxacin	-2.0	± 0.95
Placebo	0.1	± 0.94

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.2	± 1.04
Supratherapeutic Dose: ITF2357 300 mg	-3.4	± 1.01
Moxifloxacin	-2.6	± 1.03
Placebo	0.1	± 1.01

Change From Baseline in QRS Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

The cardio-dynamic assessment was performed through 12-lead ECGs extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. QRS interval is the time from electrocardiogram Q wave to the end of the S wave, corresponding to ventricle depolarization.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.1	± 0.14
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.13
Moxifloxacin	0.2	± 0.14
Placebo	0.2	± 0.13

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.2	± 0.16
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.16
Moxifloxacin	0.4	± 0.16
Placebo	0.0	± 0.16

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.0	± 0.16
Supratherapeutic Dose: ITF2357 300 mg	0.0	± 0.16
Moxifloxacin	-0.1	± 0.16
Placebo	-0.1	± 0.16

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.1	± 0.15
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.15
Moxifloxacin	0.2	± 0.15
Placebo	0.0	± 0.15

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.1	± 0.17
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.16
Moxifloxacin	0.3	± 0.16
Placebo	0.1	± 0.16

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.17
Supratherapeutic Dose: ITF2357 300 mg	0.4	± 0.17
Moxifloxacin	0.3	± 0.17
Placebo	0.3	± 0.17

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.18
Supratherapeutic Dose: ITF2357 300 mg	0.5	± 0.17
Moxifloxacin	0.1	± 0.18
Placebo	0.3	± 0.17

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.20
Supratherapeutic Dose: ITF2357 300 mg	0.4	± 0.19
Moxifloxacin	0.3	± 0.20
Placebo	0.2	± 0.19

Change From Baseline in Heart Rate (HR) Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

The cardio-dynamic assessment was performed through 12-lead ECGs extracted from continuous recordings at pre-specified time points. Participants rested in supine position for at least 10 minutes prior to and 5 minutes after each time point for ECG extractions. Baseline is defined as the last results (scheduled or unscheduled) obtained prior to drug administration in each period.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.6	± 0.76
Supratherapeutic Dose: ITF2357 300 mg	1.1	± 0.75
Moxifloxacin	1.3	± 0.75
Placebo	0.5	± 0.75

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1.2	± 0.85
Supratherapeutic Dose: ITF2357 300 mg	2.8	± 0.83
Moxifloxacin	2.3	± 0.84
Placebo	1.1	± 0.83

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.3	± 0.85
Supratherapeutic Dose: ITF2357 300 mg	5.1	± 0.83
Moxifloxacin	1.9	± 0.84
Placebo	1.1	± 0.84

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.7	± 0.86
Supratherapeutic Dose: ITF2357 300 mg	7.8	± 0.84
Moxifloxacin	1.4	± 0.85
Placebo	1.1	± 0.84

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.8	± 0.99
Supratherapeutic Dose: ITF2357 300 mg	9.9	± 0.97
Moxifloxacin	0.9	± 0.98
Placebo	0.5	± 0.97

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	4.3	± 0.86
Supratherapeutic Dose: ITF2357 300 mg	10.5	± 0.84
Moxifloxacin	1.4	± 0.85
Placebo	0.7	± 0.84

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	4.0	± 0.89
Supratherapeutic Dose: ITF2357 300 mg	9.9	± 0.87
Moxifloxacin	2.2	± 0.88
Placebo	0.1	± 0.87

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	4.3	± 0.94
Supratherapeutic Dose: ITF2357 300 mg	11.0	± 0.92
Moxifloxacin	2.3	± 0.93
Placebo	1.3	± 0.92

Placebo-corrected Change From Baseline in PR Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

Placebo-corrected change from Baseline in PR, (ΔΔPR) was calculated based on model-predicted effect. PR interval was the time between the beginning of the P wave and the start of the QRS interval, corresponding to the end of atrial depolarization and onset of ventricular depolarization.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.2	± 1.02
Supratherapeutic Dose: ITF2357 300 mg	-0.9	± 1.00
Moxifloxacin	-0.1	± 1.01

1 hour Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-1.9	± 1.34
Supratherapeutic Dose: ITF2357 300 mg	-1.6	± 1.31
Moxifloxacin	-2.6	± 1.32

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.6	± 1.33
Supratherapeutic Dose: ITF2357 300 mg	-1.5	± 1.30
Moxifloxacin	-1.6	± 1.31

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-1.2	± 1.34
Supratherapeutic Dose: ITF2357 300 mg	-2.9	± 1.31
Moxifloxacin	-1.7	± 1.32

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-3.2	± 1.32
Supratherapeutic Dose: ITF2357 300 mg	-3.1	± 1.30
Moxifloxacin	-2.6	± 1.31

3 hour Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-1.4	± 1.32
Supratherapeutic Dose: ITF2357 300 mg	-1.8	± 1.30
Moxifloxacin	-1.5	± 1.31

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.7	± 1.23
Supratherapeutic Dose: ITF2357 300 mg	-2.9	± 1.21
Moxifloxacin	-2.1	± 1.22

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-2.3	± 1.35
Supratherapeutic Dose: ITF2357 300 mg	-3.5	± 1.32
Moxifloxacin	-2.6	± 1.33

Placebo-corrected Change From Baseline in QRS Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

Placebo-corrected change from baseline for QRS interval, (ΔΔQRS) was calculated based on model-predicted effect. QRS interval is the time from Q wave to the end of the S wave, corresponding to ventricle depolarization.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.2	± 0.17
Supratherapeutic Dose: ITF2357 300 mg	0.0	± 0.16
Moxifloxacin	0.1	± 0.17

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.21
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.20
Moxifloxacin	0.4	± 0.20

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.21
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.20
Moxifloxacin	0.0	± 0.20

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.0	± 0.19
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.19
Moxifloxacin	0.3	± 0.19

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.2	± 0.21
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.20
Moxifloxacin	0.2	± 0.21

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.2	± 0.22
Supratherapeutic Dose: ITF2357 300 mg	0.1	± 0.22
Moxifloxacin	0.0	± 0.22

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	-0.3	± 0.23
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.23
Moxifloxacin	-0.2	± 0.23

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.0	± 0.26
Supratherapeutic Dose: ITF2357 300 mg	0.2	± 0.26
Moxifloxacin	0.2	± 0.26

Placebo-corrected Change From Baseline in HR Interval Secondary · At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

Placebo-corrected change from baseline in HR, (ΔΔHR) was calculated based on model-predicted effect.

0.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.73
Supratherapeutic Dose: ITF2357 300 mg	0.6	± 0.71
Moxifloxacin	0.8	± 0.72

1 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0.1	± 0.89
Supratherapeutic Dose: ITF2357 300 mg	1.6	± 0.88
Moxifloxacin	1.2	± 0.88

1.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.2	± 0.90
Supratherapeutic Dose: ITF2357 300 mg	4.0	± 0.88
Moxifloxacin	0.8	± 0.89

2 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2.6	± 0.92
Supratherapeutic Dose: ITF2357 300 mg	6.7	± 0.90
Moxifloxacin	0.3	± 0.91

2.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.3	± 1.15
Supratherapeutic Dose: ITF2357 300 mg	9.3	± 1.13
Moxifloxacin	0.3	± 1.14

3 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.6	± 0.91
Supratherapeutic Dose: ITF2357 300 mg	9.8	± 0.90
Moxifloxacin	0.7	± 0.91

3.5 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.9	± 0.96
Supratherapeutic Dose: ITF2357 300 mg	9.8	± 0.95
Moxifloxacin	2.1	± 0.96

4 hours Post-dose

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	3.0	± 1.06
Supratherapeutic Dose: ITF2357 300 mg	9.7	± 1.04
Moxifloxacin	1.0	± 1.05

Number of Participants With Changes in Categorical Outliers for QTcF, PR, and QRS Intervals in the ECG and HR Secondary · Baseline, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, and 36 hours post-dose

QTcF: Treatment-emergent value of greater than (\>) 450 and less than or equal to (\<=) 480 ms when not present at Baseline (new onset). Treatment-emergent value of \> 480 and \<= 500 ms when not present at Baseline (new onset). Treatment-emergent value of \> 500 ms when not present at Baseline (new onset). Increase of QTcF (ΔQTcF) from Baseline of \> 30 and \<= 60 ms. Increase of QTcF from Baseline \> 60 ms HR: Decrease of HR from Baseline \> 25% resulting in HR less than (\<) 50 bpm. Increase of HR from Baseline \> 25% resulting in HR \> 100 bpm. PR: Increase of PR from Baseline \> 25

QTcF > 450 and <= 480 ms

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	1
Moxifloxacin	2
Placebo	0

QTcF > 480 and <= 500 ms

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

QTcF > 500 ms

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

ΔQTcF > 30 and <= 60 ms

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	2
Moxifloxacin	2
Placebo	0

ΔQTcF > 60 ms

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

HR < 50 (bpm) with a decrease in ΔHR > 25%

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

HR > 100 (bpm) with an increase in ΔHR > 25%

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

PR > 210 (ms) with an increase in ΔPR > 25%

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Number of Participants With Treatment-Emergent Changes of T-Wave Morphology and U Wave Presence Secondary · Up to 44 days

T-wave abnormalities were categorized as follows: Normal T wave (+): Any positive T wave not meeting any criterion below. Flat T wave: T amplitude \< 1 mm (either positive or negative) including flat isoelectric line. Notched T wave (+): Presence of notch(es) of at least 0.05 mV amplitude on ascending or descending arm of the positive T wave. Biphasic: T wave that contains a second component with an opposite phase that is at least 0.1 mV deep (both positive/negative and negative/positive and polyphasic T waves included). Normal T wave (-): T amplitude that is negative, without biphasic T w

Flat

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Notched (+)

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Biphasic

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Normal (-)

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Notched (-)

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

U-Wave presence

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	0
Supratherapeutic Dose: ITF2357 300 mg	0
Moxifloxacin	0
Placebo	0

Plasma Pharmacokinetic (PK): Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of ITF2357 and Its Metabolites Secondary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, 60, and 72 hours post-dose

The area under the concentration time curve (AUC) from time zero (= dosing time) to the last sampling time (tlast) at which the concentration is at or above the lower limit of quantification. AUC0-t was calculated using the mixed log-linear trapezoidal rule (linear up, log down). AUC0-t of ITF2357 and metabolites: ITF2374, ITF2375, ITF2440, ITF2563, and ITF2955 glucuronide were reported.

ITF2357

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	596.10	± 22.57
Supratherapeutic Dose: ITF2357 300 mg	2313.44	± 20.53

ITF2374

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	363.55	± 63.83
Supratherapeutic Dose: ITF2357 300 mg	1296.22	± 59.65

ITF2375

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	2672.92	± 54.88
Supratherapeutic Dose: ITF2357 300 mg	9599.11	± 52.70

ITF2440

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	5696.28	± 23.36
Supratherapeutic Dose: ITF2357 300 mg	18577.74	± 21.34

ITF2563

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1247.92	± 23.58
Supratherapeutic Dose: ITF2357 300 mg	3563.33	± 20.59

ITF2955 glucuronide

Group	Value	95% CI
Therapeutic Dose: ITF2357 100 mg	1.53	± 78.00
Supratherapeutic Dose: ITF2357 300 mg	15.89	± 47.69

Plasma PK: Area Under the Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Moxifloxacin Secondary · Pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12, 24, 36, 48, 60, and 72 hours post-dose

Group	Value	95% CI
Moxifloxacin	27077.52	± 16.17

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to 44 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Therapeutic Dose: ITF2357 100 mg

Serious: 0/29 (0%)

Deaths: 0/29

Supratherapeutic Dose: ITF2357 300 mg

Serious: 0/31 (0%)

Deaths: 0/31

Placebo

Serious: 0/31 (0%)

Deaths: 0/31

Moxifloxacin

Serious: 0/31 (0%)

Deaths: 0/31

Other adverse events (23 terms — click to expand)

Reaction	System	Therapeutic Dose: ITF2357 …	Supratherapeutic Dose: ITF…	Placebo	Moxifloxacin
Nausea	Gastrointestinal disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Eructation	Gastrointestinal disorders	—	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—	—
Disturbance in attention	Nervous system disorders	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—
White blood cells urine positive	Investigations	—	—	—	—
Blood triglycerides increased	Investigations	—	—	—	—
Heart rate irregular	Investigations	—	—	—	—
Sensation of foreign body	General disorders	—	—	—	—
Vessel puncture site haematoma	General disorders	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—
Pain in jaw	Musculoskeletal and connective tissue disorders	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nasal dryness	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Folliculitis	Infections and infestations	—	—	—	—

Data from ClinicalTrials.gov NCT04821063 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Thorough QT Study on the Effect of Therapeutic and Supratherapeutic Dosing of Givinostat in Healthy Volunteers
Mercuri E, Byrne B, Willis T, Bourke J, et al · · 2026

Verify or expand the search:

Other Italfarmaco trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04821063 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Italfarmaco
Last refreshed: 11 January 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04821063.

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NCT04821063

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other Italfarmaco trials

Verify against primary sources