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Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin

COPD Clinical Trial

Official title:
An Open-label, Healthy Subject, Two-part Study to Assess the Effect of Verapamil on Systemic Exposure of EP395 (Part A), and to Assess the Effect of EP395 on Systemic Exposure of Midazolam and Digoxin (Part B)

Clinical Trial Summary

The aim of this trial is to assess the potential key drug-drug interactions with EP395 in the clinical setting.

Clinical Trial Description

This is an open-label, healthy subject, two-part study to assess the effect of verapamil on systemic exposure of EP395 (Part A), and to assess the effect of EP395 on systemic exposure of midazolam and digoxin (Part B). The overall aim of this trial is to assess the potential key drug-drug interactions (DDIs) with EP395 in the clinical setting. The trial will be in two parts: Part A will investigate EP395 as a 'victim' of DDIs. The impact of CYP3A4 and P-glycoprotein (Pgp) inhibition on the pharmacokinetics (PK) of EP395 will be assessed. Verapamil has been selected as a moderate inhibitor of CYP3A4 and an inhibitor of Pgp. Part B will investigate EP395 as a 'perpetrator' of DDIs. The impact of EP395 on the PK of a CYP3A4 substrate and a Pgp substrate will be assessed. Midazolam has been selected as the CYP3A4 substrate and digoxin as the Pgp substrate. The trial population is healthy adults. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06118684
Study type Interventional
Source EpiEndo Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date October 23, 2023
Completion date January 2, 2024
View Details
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