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Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

NCT03750383 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-02-12

No results posted yet for this study

Summary

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

Conditions

  • RSV Infection

Interventions

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)

DRUG

EDP-938

Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)

DRUG

Cyclosporine

Subjects will receive one dose of cyclosporine on Day 5

DRUG

Prednisone

Subjects will receive prednisone once daily from Day 5 to Day 14

Sponsors & Collaborators

  • Pharmaceutical Research Associates

    collaborator OTHER

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · 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
2018-11-02
Primary Completion
2018-11-17
Completion
2018-12-13
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 NCT03750383 on ClinicalTrials.gov