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

NCT ID: NCT04871724

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-12
• Study Completion Date: 2021-04-16

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EDP-938 and Fluconazole interaction

Group Type: EXPERIMENTAL

EDP-938

Intervention Type: DRUG

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

Fluconazole

Intervention Type: DRUG

Subjects will receive fluconazole once daily on Days 5 to 18

Interventions

EDP-938

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

Intervention Type: DRUG

Fluconazole

Subjects will receive fluconazole once daily on Days 5 to 18

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

Pharmaceutical Research Associates, Inc.,

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

EDP 938-007

Identifier Type: -

Identifier Source: org_study_id