Drug-Drug Interaction Study Between Fluconazole and EDP-938 in Healthy Subjects

NCT04871724 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 938-007
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects

Conditions

RSV Infection

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (2)

• Cmax of EDP-938 with and without coadministration with fluconazole

  Up to 19 days

• AUC of EDP-938 with and without coadministration with fluconazole

  Up to 19 days

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 25 Days

Study Arms (1)

EDP-938 and Fluconazole interaction

EXPERIMENTAL

Drug: EDP-938; Drug: Fluconazole

Interventions

EDP-938 DRUG

Subjects will receive EDP-938 once daily on Days 1 and 14

EDP-938 and Fluconazole interaction

Fluconazole DRUG

Subjects will receive fluconazole once daily on Days 5 to 18

EDP-938 and Fluconazole interaction

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 55 years, inclusive.
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg
• Female subjects of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 90 days after the last dose of EDP 938.

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.
• Participation in a clinical trial within 30 days prior to the first dose of study drug.
• Clinically significant history of drug sensitivity or allergy to fluconazole or other azole antifungals

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938; 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

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 4, 2021
• Study Start: March 12, 2021
• Primary Completion: March 30, 2021
• Study Completion: April 16, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)