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Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects

NCT03755778 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2019-06-14

No results posted yet for this study

Summary

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

Conditions

  • RSV Infection

Interventions

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)

DRUG

Itraconazole

Subjects will receive itraconazole once daily from Day 5 to Day 18

DRUG

Rifampin

Subjects will receive rifampin once daily from Day 5 to Day 16

DRUG

Quinidine

Subjects will receive quinidine once daily from Day 5 to Day 12

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals · Enanta Pharmaceuticals, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-29
Primary Completion
2019-01-21
Completion
2019-01-27
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03755778 on ClinicalTrials.gov