Adults 18 to 55, any sex, with Drug Drug Interaction. 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.
Plasma Pharmacokinetic (PK) Parameters of Givinostat, Following First Single-dose Administration of Givinostat: CmaxPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1.
Cmax is the Maximum Observed Plasma Concentration. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 22 blood samples were collected as follows:
\- 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Days 1, for the determination of Givinostat and its metabolites plasma concentrations using a validated LC-MS/MS analytical method.
Summary Statistics for the main PK parameters, like Cmax, Following Single-Dose Administration of Givinostat (Day 1)
Group
Value
95% CI
Givinostat
48.06
± 25.8
ITF2374
7.34
± 45.7
ITF2375
132.20
± 40.2
ITF2440
88.77
± 16.4
ITF2563
15.38
± 13.8
Plasma PK Parameters of Givinostat, Following First Single-dose Administration of Givinostat: TmaxPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1.
Tmax is the Time to Maximum Observed Concentration.The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 22 blood samples were collected as follows:
\- 22 blood samples at predose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Days 1, for the determination of Givinostat and its metabolites plasma concentrations.
Summary Statistics for the main PK parameters, like tmax, Following Single-Dose Administration of Givinostat (Day 1) are reported.
Group
Value
95% CI
Givinostat
1.50
1.00 – 3.50
ITF2374
5.50
5.00 – 12.00
ITF2375
3.50
2.00 – 4.00
ITF2440
9.00
8.00 – 12.00
ITF2563
10.00
8.00 – 12.00
Plasma PK Parameters of Givinostat, Following First Single-dose and Following Multiple-Dose Administration of Givinostat: CtroughPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1 and on Day 13.
Ctrough is the Pre-dose Plasma Concentration. On Day 1 and Day 13, Givinostat 50 mg as oral suspension was administered as a single dose, in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. From Day 5 to Day 12 Givinostat 50 mg as oral suspension was administered twice daily.
A total of 48 blood samples were collected:
* 22 during single-dose treatment (Day 1, at pre-dose and at the timepoints indicated in the timeframe post-dose) and
* 26 during the multiple dose treatment (Days 5-12 plus single-dose treatment at
single dose (Day 1)
Group
Value
95% CI
Givinostat
6.75
± 22.3
ITF2374
4.14
± 42.6
ITF2375
28.47
± 53.3
ITF2440
81.58
± 14.9
ITF2563
14.75
± 11.1
multiple dose (Day 13)
Group
Value
95% CI
Givinostat
13.16
± 28.7
ITF2374
10.18
± 50.8
ITF2375
56.12
± 60.6
ITF2440
279.96
± 15.6
ITF2563
50.11
± 18.8
Plasma PK Parameters of Givinostat, Following First Single-dose and Following Multiple-dose Administration of Givinostat: AUC0-inf.Primary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1 and on Day 13.
AUC0-inf is the AUC from Time Zero to Infinity. On Day 1 and Day 13, givinostat 50 mg as oral suspension was administered as a single dose, in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. From Day 5 to Day 12 givinostat 50 mg as oral suspension was administered twice daily.
A total of 48 blood samples were collected:
* 22 during single-dose treatment (Day 1, at pre-dose and at the timepoints indicated in the timeframe post-dose) and
* 26 during the multiple dose treatment (Days 5-12 plus single-dose treatment a
Single-dose (Day 1)
Group
Value
95% CI
Givinostat
305.72
± 21.0
ITF2374
99.01
± 49.1
ITF2375
1239.34
± 47.8
ITF2440
2431.31
± 12.1
ITF2563
457.95
± 13.4
Multiple-dose (Day 13)
Group
Value
95% CI
Givinostat
562.42
± 17.5
ITF2374
337.71
± 53.2
ITF2375
2754.89
± 77.8
ITF2440
9526.56
± 30.2
ITF2563
1715.62
± 23.0
Plasma PK Parameters of Givinostat, Following First Single-dose and Following Multiple-dose Administration of Givinostat: AUC0-t.Primary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1 and on Day 13.
AUC0-t is the AUC from Time Zero to Last Sampling Time with Quantifiable. On Days 1 and 13, Givinostat 50 mg as oral suspension was administered as a single dose, in the morning, following an overnight fasting of at least 8 h and subjects remained fasted until at least 4 h post-dose. From Day 5 to Day 12 Givinostat 50 mg as oral suspension was administered twice daily.
48 blood samples were collected in total:
* 22 during single-dose treatment (Day 1, at pre-dose and at the timepoints indicated in the timeframe post-dose),
* 26 during the multiple dose treatment (Days 5-12 plus single-dose t
Single-dose (Day 1)
Group
Value
95% CI
Givinostat
300.45
± 21.3
ITF2374
93.30
± 51.0
ITF2375
1223.60
± 47.5
ITF2440
2345.60
± 12.7
ITF2563
439.59
± 13.0
Multiple-dose (Day 13)
Group
Value
95% CI
Givinostat
554.78
± 17.5
ITF2374
328.36
± 53.9
ITF2375
2609.03
± 68.2
ITF2440
9262.28
± 27.4
ITF2563
1681.26
± 21.8
Plasma PK Parameters of Givinostat, Following First Single-dose Administration of Givinostat: AUC0-τPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1.
AUC0-τ is the area under the plasma concentration versus time curve. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 22 blood samples were collected as follows:
\- 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Days 1, for the determination of Givinostat and its metabolites plasma concentrations.
Summary Statistics for the main PK parameters, like AUC0-τ, Following Single-Dose Administration of Givinostat (Day 1) are reported.
Group
Value
95% CI
Givinostat
245.73
± 23.2
ITF2374
52.48
± 42.2
ITF2375
806.71
± 40.6
ITF2440
681.56
± 25.8
ITF2563
99.71
± 23.1
Plasma PK Parameters of Givinostat, Following First Single-dose and Following Multiple-dose Administration of Givinostat: %AUCextrapPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1 and on Day 13.
Area under the curve (AUC) is used to describe the total exposure to a drug. The total AUC (AUC0-∞) is the area under the curve from time 0 extrapolated to infinite time. %AUCextrap is the Residual Area or Percentage of Extrapolated Part of AUC0-∞.
On Days 1 and 13, givinostat 50 mg as oral suspension was administered as a single dose, in the morning, following an overnight fasting of at least 8 h and subjects remained fasted until at least 4 h post-dose. From Day 5 to Day 12 Givinostat 50 mg as oral suspension was administered twice daily.
A total of 48 samples were collected as already des
Single-dose (Day 1)
Group
Value
95% CI
Givinostat
1.69
± 21.7
ITF2374
5.39
± 39.8
ITF2375
0.93
± 97.7
ITF2440
3.46
± 20.9
ITF2563
3.96
± 16.3
Multiple-dose (Day 13)
Group
Value
95% CI
Givinostat
1.33
± 20.6
ITF2374
2.56
± 45.2
ITF2375
2.13
± 220.0
ITF2440
1.84
± 112.1
ITF2563
1.53
± 82.8
Plasma PK Parameters of Givinostat, Following First Single-dose and Following Multiple-dose Administration of Givinostat: λzPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1 and on Day 13.
λz is the Apparent Terminal Elimination Rate Constant. On Day 1 and Day 13, Givinostat 50 mg as oral suspension was administered as a single dose, in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. From Day 5 to Day 12 Givinostat 50 mg as oral suspension was administered twice daily.
A total of 48 blood samples were collected:
* 22 during single-dose treatment (Day 1, at pre-dose and at the timepoints indicated in the timeframe post-dose) and
* 26 during the multiple dose treatment (Days 5-12 plus single-dose trea
Single-dose (Day 1)
Group
Value
95% CI
Givinostat
0.097
± 15.6
ITF2374
0.094
± 33.0
ITF2375
0.062
± 34.2
ITF2440
0.060
± 15.2
ITF2563
0.055
± 27.8
Multiple-dose (Day 13)
Group
Value
95% CI
Givinostat
0.067
± 24.8
ITF2374
0.064
± 22.5
ITF2375
0.037
± 71.6
ITF2440
0.047
± 49.8
ITF2563
0.052
± 31.5
Plasma PK Parameters of Givinostat, Following First Single-dose Administration of Givinostat: t1/2Primary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1.
t1/2 is the Apparent Terminal Half-Life. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 22 blood samples were collected as follows:
\- 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Days 1, for the determination of Givinostat and its metabolites plasma concentrations.
Summary Statistics for the main PK parameters, like t1/2, Following Single-Dose Administration of Givinostat (Day 1) are reported.
Group
Value
95% CI
Givinostat
7.16
± 15.7
ITF2374
7.40
± 32.8
ITF2375
11.21
± 34.4
ITF2440
11.65
± 15.4
ITF2563
12.57
± 27.8
Plasma PK Parameters of Givinostat, Following First Single-dose Administration of Givinostat: Vd/FPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 1.
Vd/F is the Apparent volume of distribution. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 22 blood samples were collected as follows:
\- 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Days 1, for the determination of Givinostat and its metabolites plasma concentrations.
Summary Statistics for the main PK parameters, like Vd/F, Following Single-Dose Administration of Givinostat (Day 1) are reported.
Group
Value
95% CI
Givinostat
1690.43
± 21.7
ITF2374
0000
± 0000
ITF2375
0000
± 0000
ITF2440
0000
± 0000
ITF2563
0000
± 0000
Plasma PK Parameters of Givinostat, Following Multiple-dose Administration of Givinostat: Cmax,ssPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 13.
Cmax,ss is the Maximum Observed Plasma Concentration at steady state. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported on this platform).
A total of 26 blood samples were collected as follows:
* 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Day 13, for the determination of Givinostat and its metabolites plasma concentrations.
* 4 blood samples before the morning dose of on Days 9, 10, 11 and 12, for the determination of pre-dose plasma concentration of Givinostat and
Group
Value
95% CI
Givinostat
75.50
± 27.0
ITF2374
20.52
± 38.6
ITF2375
217.29
± 38.1
ITF2440
306.60
± 15.2
ITF2563
55.37
± 20.3
Plasma PK Parameters of Givinostat, Following Multiple-dose Administration of Givinostat: Tmax,ssPrimary· At 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 15, 24, 36, 48, 60, 72, 84 and 96 hours post dose on Day 13.
Tmax,ss is the Time of occurrence of Cmax,ss. The Givinostat metabolites were: ITF2374, ITF2375, ITF2440, ITF2563 (not reported in this platform).
A total of 26 blood samples were collected as follows:
* 22 blood samples at pre-dose and at the timepoints indicated in the timeframe field after the administration of Givinostat (post-dose), on Day 13, for the determination of Givinostat and its metabolites plasma concentrations.
* 4 blood samples before the morning dose of on Days 9, 10, 11 and 12, for the determination of pre-dose plasma concentration of Givinostat and its metabolites.
Summar
Group
Value
95% CI
Givinostat
1.50
1.50 – 3.00
ITF2374
5.50
5.00 – 6.00
ITF2375
3.50
2.05 – 4.00
ITF2440
10.00
4.00 – 12.00
ITF2563
9.00
6.00 – 10.00
Adverse events — posted to ClinicalTrials.gov
Time frame: Throughout the study and 10-14 days after the End of Study (follow-up visit), i.e. up to day 30-34, all TEAEs, considered related or not related to IMPs, were collected..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary objective:
To evaluate the plasma and urine PK of Givinostat following multiple oral doses of Givinostat.
Secondary objective:
To assess the safety and tolerability multiple oral doses of Givinostat.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05845567 — The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)
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· NA
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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: 24 January 2025
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/NCT05860114.