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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

Outcome

Met primary endpoint

registry analysis (superiority test); Givinostat Alone (Day 1) vs Givinostat Co-Administered With Clarithromycin (Day 8); ratio of the Geometric LSmeans 139.43 (90% CI 129.73 to 149.86) NCT05845567 ↗

registry analysis (superiority test); Givinostat Alone (Day 1) vs Givinostat Co-Administered With Clarithromycin (Day 8); ratio of the Geometric LSmeans 117.97 (90% CI 112.24 to 124.00) NCT05845567 ↗

registry analysis (superiority test); Givinostat Alone (Day 1) vs Givinostat Co-Administered With Clarithromycin (Day 8); ratio of the Geometric LSmeans 117.88 (90% CI 112.13 to 123.92) NCT05845567 ↗

Drugs

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

Indications

No indication recorded.