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

Sponsor
Italfarmaco
Study ID
NCT05845567
Phase
PHASE1
Status
Completed

Conditions

  • Drug Drug Interaction

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 21, 2022
Status verified
Jul 2024
Primary completion
May 8, 2022
Completion
May 24, 2022

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Givinostat + Clarithromycin
    Givinostat and Clarithromycin Days 1 and 8, Givinostat 50 mg as oral suspension was administered as a single dose, 1 hour after Clarithromycin administration. From Day 4 to Day 10, Clarithromycin 500 mg film-coated tablet was administered twice a day.

Primary Outcome Measure

Cmax of Givinostat, Following Single Doses of the Parent Drug [ Time Frame: In the turn of 72 hours after administration of Givinostat ]