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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

NCT06118684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-04-29

No results posted yet for this study

Summary

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

Conditions

  • Chronic Obstructive Pulmonary Disease Exacerbation
  • COPD

Interventions

DRUG

EP395 (Part A and B)

EP395 (test product) oral capsule 125 mg. Part A: Dose: 1 capsule as a single dose on Day 1 and Day 14, total daily dose: 125 mg. Part B: Dose: 3 capsules once daily on Days 9 to 28, total daily dose: 375 mg.

DRUG

Verapamil (Part A)

Verapamil (CYP3A4/Pgp inhibitor), tablet 40 mg. Part A: Dose: 3 tablets twice daily Days 10 to 18, total daily dose: 240 mg.

DRUG

Midazolam (Part B)

Midazolam (CYP3A4 substrate) oral solution 1 mg/mL. Part B: Dose: 4 mL as a single dose on Day 1 and Day 24, total daily dose: 4 mg.

DRUG

Digoxin (Part B)

Digoxin (Pgp substrate) tablet 0.25 mg. Part B: Dose: 1 tablet as a single dose on Day 1 and Day 24, total daily dose: 0.25 mg.

Sponsors & Collaborators

  • CTC Clinical Trial Consultants AB

    collaborator INDUSTRY

  • EpiEndo Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Björn Schultze, MD · CTC Clinical Trial Consultants AB

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-23
Primary Completion
2024-01-02
Completion
2024-01-02
FDA Drug
Yes

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06118684 on ClinicalTrials.gov