NCT06118684 - Clinical Trial to Assess Effect of Verapamil on Systemic Exposure of EP395 and Effect of EP395 on Systemic Exposure of Midazolam and Digoxin | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 23, 2023

Primary Completion Date

January 2, 2024

Study Completion Date

January 2, 2024

Conditions

Chronic Obstructive Pulmonary Disease ExacerbationCOPD

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.

Trial Locations (1)

75237

Clinical Trial Consultants AB, Uppsala