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drugset / Trial / NCT05492318

Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity

NCT05492318 ↗

Phase 1 Completed 26 enrolled Italfarmaco
NaSingle-groupOpen-labelTreatment

Summary

Primary objective: 1. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose pharmacokinetics (PK) of intravenous or oral midazolam. 2. To assess the potential inhibitory and inducing effect of oral givinostat on the single dose PK of oral dabigatran etexilate. Secondary objective: To assess the safety and tolerability of concomitant administration of givinostat plus midazolam and dabigatran etexilate.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Dabigatran etexilate Unknown 75 mg Oral
Subject Givinostat Small molecule 50 mg Oral
Subject Midazolam Small molecule 1 mg Intravenous
Subject Midazolam Small molecule 2.5 mg Intravenous

Indications

No indication recorded.