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

Overview

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

Full Title of Study: “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”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: March 30, 2021

Interventions

• Drug: EDP-938
  • Subjects will receive EDP-938 once daily on Days 1 and 14
• Drug: Fluconazole
  • Subjects will receive fluconazole once daily on Days 5 to 18

Arms, Groups and Cohorts

• Experimental: EDP-938 and Fluconazole interaction

Clinical Trial Outcome Measures

Primary Measures

• Cmax of EDP-938 with and without coadministration with fluconazole
  • Time Frame: Up to 19 days
• AUC of EDP-938 with and without coadministration with fluconazole
  • Time Frame: Up to 19 days

Secondary Measures

• Safety measured by adverse events
  • Time Frame: Up to 25 Days

Participating in This Clinical Trial

Inclusion 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Enanta Pharmaceuticals, Inc
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Enanta Pharmaceuticals, Inc, Study Director, Enanta Pharmaceuticals, Inc