NCT05845567

The Potential of Givinostat as DDI Victim in Co-administration P-gp Inhibitor (Part 2)

An Open-label, Single-center, Study in Healthy Subjects to Investigate the Effect of Oral Clarithromycin on the Pharmacokinetics of Givinostat (PART 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Italfarmaco · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Primary objective: To assess the potential effect of oral Clarithromycin on the single-dose pharmacokinetics of Givinostat. Secondary objective: To assess the safety and tolerability of concomitant administration of Givinostat plus Clarithromycin.

Detailed description

This study was planned as a phase I, open-label, 3-part, fixed-sequence, non-randomized study in healthy male and female subjects. The study (Part 2) aimed at assessing the potential effect of Clarythromycin on the single dose pharmacokynetics of Givinostat. The total duration of Part 2 was divided as follows: * Screening: up to 21 days. * Treatment Period: Days 1 to 11. * Safety follow-up visit: 12±2 days. Subjects were confined at site from Day -1 to Day 11. On Days 1 and 8, a single dose of 50 mg Givinostat, as oral suspension, was administered 1 hour after the planned morning time of Clarithromycin administration. From Day 4 to Day 10, clarithromycin 500 mg film-coated tablets were administered twice a day, in the morning and in the evening. The following assessments were performed: * Blood collection for pharmacokinetic analysis on Days 1 to 4 and 8 to 11. * Vital signs measurements on Days 1 and 4 to 10. * 12-lead ECG on Days 1, 3, 7 and 8. * Blood collection for laboratory tests (hematology and biochemistry) on Day 3. Subjects were discharged in the morning of Day 11 after completing end of study procedures.

Conditions

• Drug Drug Interaction

Interventions

Type	Name	Description
DRUG	Givinostat	ITF2357 Givinostat 10mg/mL. Dose: 10 mg/mL; Dosage form: oral suspension.
DRUG	Clarithromycin	Clarithromycin 500 mg immediate-release oral film-coated tablet (Klacid®) was administered twice a day, in the morning and in the evening.

Timeline

• Start date: 2022-03-21
• Primary completion: 2022-05-08
• Completion: 2022-05-24
• First posted: 2023-05-06
• Last updated: 2024-08-16
• Results posted: 2024-02-09

Locations

1 site across 1 country: Portugal

Regulatory

• FDA-regulated drug study