NCT03610945

Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers

• 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

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Fluconazole	Subjects will receive fluconazole once daily from Day 5 to Day 18
DRUG	Quinidine	Subjects will receive quinidine twice daily from Day 5 to Day 12
DRUG	EDP-305	Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
DRUG	EDP-305	Subjects will receive a single dose of EDP-305 on Day 1 and Day 8

Timeline

• Start date: 2018-07-19
• Primary completion: 2018-08-15
• Completion: 2018-08-21
• First posted: 2018-08-01
• Last updated: 2018-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study