NCT03755778

Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (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 Itraconazole, Rifampin, and Quinidine 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 Day 1 and 14 (Part 1)
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)
DRUG	EDP-938	Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)
DRUG	Itraconazole	Subjects will receive itraconazole once daily from Day 5 to Day 18
DRUG	Rifampin	Subjects will receive rifampin once daily from Day 5 to Day 16
DRUG	Quinidine	Subjects will receive quinidine once daily from Day 5 to Day 12

Timeline

• Start date: 2018-11-29
• Primary completion: 2019-01-21
• Completion: 2019-01-27
• First posted: 2018-11-28
• Last updated: 2019-06-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study