drugset / Trial / NCT05845567

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

NCT05845567

Phase 1 Completed 20 enrolled Italfarmaco
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-03-21
Primary completion
2022-05-08
Completion
2022-05-24

Drugs

EvaluationDrugModalityDoseRoute
Subject Clarithromycin Small molecule 500 mg Oral
Subject Givinostat Small molecule 50 mg Oral

Indications

No indication recorded.