NCT04498741

Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)
DRUG	Tacrolimus	Subjects will receive tacrolimus once daily on Day 1 and Day 24
DRUG	Dabigatran	Subjects will receive dabigatran once daily on Day 1 and Day 13
DRUG	Rosuvastatin	Subjects will receive rosuvastatin once daily on Day 1 and Day 13
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)
DRUG	Midazolam	Subjects will receive midazolam once daily on Day 1 and Day 16

Timeline

• Start date: 2020-07-08
• Primary completion: 2021-05-27
• Completion: 2021-06-01
• First posted: 2020-08-04
• Last updated: 2021-10-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study