NCT06847464

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine, and Fluconazole on the Pharmacokinetics and Safety of EDP-323 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Enanta Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.

Conditions

• RSV Infection
• Drug Drug Interaction (DDI)

Interventions

Type	Name	Description
DRUG	EDP-323	Subjects will receive EDP-323 on Days 1 and 14
DRUG	Itraconazole	Subjects will receive itraconazole QD Days 5-18
DRUG	EDP-323	Subjects will receive EDP-323 on Days 1 and 23
DRUG	carbamazepine	Subjects will receive carbamazepine on Days 5 - 27
DRUG	EDP-323	Subjects will receive EDP-323 on Days 1 and 8
DRUG	Quinidine	Subjects will receive quinidine on Days 5-12
DRUG	EDP-323	Subjects will receive EDP-323 on Days 1 and 14
DRUG	fluconazole	Subjects will receive fluconazole on Days 5-18

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-05-24
• Completion: 2025-06-01
• First posted: 2025-02-26
• Last updated: 2025-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study