NCT03213145

Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin 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 itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	intraconazole	Subjects will receive itraconazole once daily from Day 5 through Day18
DRUG	Rifampin	Subjects will receive rifampin once daily from Day 5 through Day 16
DRUG	EDP 305	Subjects will receive EDP 305 once daily on Day 1 and Day 14

Timeline

• Start date: 2017-07-11
• Primary completion: 2017-08-10
• Completion: 2017-09-07
• First posted: 2017-07-11
• Last updated: 2017-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study