NCT03750383

Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects

Conditions

• RSV Infection

Interventions

Type	Name	Description
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
DRUG	EDP-938	Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
DRUG	Cyclosporine	Subjects will receive one dose of cyclosporine on Day 5
DRUG	Prednisone	Subjects will receive prednisone once daily from Day 5 to Day 14

Timeline

• Start date: 2018-11-02
• Primary completion: 2018-11-17
• Completion: 2018-12-13
• First posted: 2018-11-23
• Last updated: 2019-02-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study