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

NCT06847464 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 323-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Drug Drug Interaction

Outcome Measures

Primary Outcomes (8)

• Cmax of EDP-323 with and without coadministration with Itraconazole

  Day 1 through Day 19

• AUC of EDP-323 with and without coadministration with Itraconazole

  Day 1 through Day 19

• Cmax of EDP-323 with and without coadministration with Carbamazepine

  Day 1 through Day 28

• AUC of EDP-323 with and without coadministration with Carbamazepine

  Day 1 through Day 28

• Cmax of EDP-323 with and without coadministration with Quinidine

  Day 1 through Day 13

• AUC of EDP-323 with and without coadministration with Quinidine

  Day 1 through Day 13

• Cmax of EDP-323 with and without coadministration with fluconazole

  Day 1 through Day 19

• AUC of EDP-323 with and without coadministration with fluconazole

  Day 1 through Day 19

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 34 Days

Study Arms (4)

EDP-323 and itraconazole interaction (Part 1)

EXPERIMENTAL

Subjects will receive EDP-323 and itraconazole on respective dosing days

Drug: EDP-323; Drug: Itraconazole

EDP-323 and carbamazepine interaction (Part 2)

EXPERIMENTAL

Subjects will receive EDP-323 and carbamazepine on respective dosing days

Drug: EDP-323; Drug: carbamazepine

EDP-323 and quinidine interaction (Part 3)

EXPERIMENTAL

Subjects will receive EDP-323 and quinidine on respective dosing days

Drug: EDP-323; Drug: Quinidine

EDP-323 and fluconazole interaction (Part 4)

EXPERIMENTAL

Subjects will receive EDP-323 and fluconazole on respective dosing days

Drug: EDP-323; Drug: fluconazole

Interventions

EDP-323 DRUG

Subjects will receive EDP-323 on Days 1 and 14

EDP-323 and itraconazole interaction (Part 1)

Itraconazole DRUG

Subjects will receive itraconazole QD Days 5-18

EDP-323 and itraconazole interaction (Part 1)

carbamazepine DRUG

Subjects will receive carbamazepine on Days 5 - 27

EDP-323 and carbamazepine interaction (Part 2)

Quinidine DRUG

Subjects will receive quinidine on Days 5-12

EDP-323 and quinidine interaction (Part 3)

fluconazole DRUG

Subjects will receive fluconazole on Days 5-18

EDP-323 and fluconazole interaction (Part 4)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-323. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

You may not qualify if:

• Clinically relevant evidence or history of illness or disease
• Pregnant or nursing females
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection
• A positive urine drug screen at Screening or Day -1
• Current tobacco smokers or use of tobacco within 3 months prior to Screening.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy)
• History of regular alcohol consumption exceeding protocol limits
• Participation in a clinical trial within 28 days prior to the first dose of study drug
• For Part 2 and Part 3 participants, the following cardiovascular abnormalities:
• QRS duration \>110 ms
• Incomplete right bundle branch block or any complete bundle branch block
• Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)
• History of unexplained syncope, structural heart disease, or clinically significant arrhythmias
• Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome
• PR interval \>220 ms or any 2nd or 3rd degree AV block

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

ICON, plc

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

Itraconazole; Carbamazepine; Quinidine; Fluconazole

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: February 26, 2025
• Study Start: January 27, 2025
• Primary Completion: May 24, 2025
• Study Completion: June 1, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)