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Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

NCT04498741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2021-10-13

No results posted yet for this study

Summary

A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam 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 Days 10 through 27 (Part 1)

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)

DRUG

Tacrolimus

Subjects will receive tacrolimus once daily on Day 1 and Day 24

DRUG

Dabigatran

Subjects will receive dabigatran once daily on Day 1 and Day 13

DRUG

Rosuvastatin

Subjects will receive rosuvastatin once daily on Day 1 and Day 13

DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)

DRUG

Midazolam

Subjects will receive midazolam once daily on Day 1 and Day 16

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
2020-07-08
Primary Completion
2021-05-27
Completion
2021-06-01
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 NCT04498741 on ClinicalTrials.gov