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

> **NCT05492318** · PHASE1 · COMPLETED · sponsor: **Italfarmaco** · enrollment: 26 (actual)

## Conditions studied

- Drug-Drug Interaction
- Heathy Volunteer

## Interventions

- **DRUG:** Givinostat 10 mg/mL
- **DRUG:** Midazolam 1mg/ml IV
- **DRUG:** Midazolam 2.5 mg oromucosal solution
- **DRUG:** Dabigatran etexilate 75 mg oral hard capsules

## Key facts

- **NCT ID:** NCT05492318
- **Lead sponsor:** Italfarmaco
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-03-21
- **Primary completion:** 2022-05-08
- **Final completion:** 2022-05-24
- **Target enrollment:** 26 (ACTUAL)
- **Last updated:** 2025-01-06


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05492318

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05492318, "Perpetrator DDI Potential of Givinostat as Inhibitor and Inducer of CYP3A and P-gp Activity". Retrieved via AI Analytics 2026-06-16 from https://api.ai-analytics.org/clinical/NCT05492318. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*