NCT04783753

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, and Quinidine on the Pharmacokinetics and Safety of EDP-514 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

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	EDP-514	Subjects will receive EDP-514 on Days 1 and 14
DRUG	EDP-514	Subjects will receive EDP-514 on Days 1 and 23
DRUG	EDP-514	Subjects will receive EDP-514 on Days 1 and 8
DRUG	Itraconazole	Subjects will receive itraconazole QD for 14 days
DRUG	Carbamazepin	Subjects will receive carbamazepine BID for 23 days
DRUG	Quinidine	Subjects will receive quinidine BID for 8 days

Timeline

• Start date: 2020-11-05
• Primary completion: 2021-06-28
• Completion: 2021-07-09
• First posted: 2021-03-05
• Last updated: 2021-08-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study