Givinostat and Metabolites Pharmacokinetics in Urine and Plasma (Part 3)
- Sponsor
- Italfarmaco
- Study ID
- NCT05860114
- Phase
- PHASE1
- Status
- Completed
Conditions
- Drug Drug Interaction
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 55 Years
- Healthy Volunteers
- Accepted
Interventions
- Givinostat — DRUGDrug: ITF2357 Givinostat 10mg/mL Dose: 10mg/mL; Dosage form: oral suspension On days 1 and 13 givinostat was administered in the morning, following an overnight fasting of at least 8 hours and subjects remained fasted until at least 4 hours post-dose. Moreover the subjects were in a semi-recumbent position and remained semi-recumbent until at least 4 hours post-dose.No fluids were allowed from 1 hour before dosing until 2 hours post-dose. Water was provided ad libitum at all other times. From Day 5 to Day 12, subjects received givinostat 50 mg as oral suspension, twice a day, in the morning and in the evening.
Study Details
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.
Key Dates
- Start date
- Mar 21, 2022
- Status verified
- Jul 2024
- Primary completion
- May 8, 2022
- Completion
- May 24, 2022
Study Design
- Enrollment
- 8 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Givinostat (single-dose and multiple-dose)On Days 1 and 13, Givinostat 50 mg as oral suspension was administered as a single dose, in the morning. On Days 5-12 Givinostat 50 mg as oral suspension was administered twice-daily, in the morning and in the evening, as a multiple dose. PK parameters values following: * single oral dose administration of Givinostat (Day 1) and * multiple oral dose administration of Givinostat (Day 5 to Day 12, with values reported at Day 13) were assessed and reported.
Primary Outcome Measure
Plasma Pharmacokinetic (PK) Parameters of Givinostat, Following First Single-dose Administration of Givinostat: Cmax [ Time Frame: 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. ]