At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Single-center, Study in Healthy Subjects to Evaluate the Plasma and Urine Pharmacokinetics of Givinostat and Its Metabolites Following Single and Multiple Oral Doses of Givinostat (Part 3).
In Brief
A Phase 1 clinical trial evaluating Givinostat for Drug Drug Interaction. Completed, enrolled 8 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
Drug: 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.