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COMPLETED
NCT06118684
PHASE1

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

Sponsor: EpiEndo Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

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)

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2023-10-23

Completion Date

2024-01-02

Last Updated

2026-04-29

Healthy Volunteers

Yes

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.

Locations (1)

Clinical Trial Consultants AB

Uppsala, Sweden