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Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.

NCT03187496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-21

No results posted yet for this study

Summary

A non-randomized, multiple-dose, open-label, single sequence study to evaluate effect of concomitant administration of EDP-305 on the pharmacokinetics and safety of midazolam, caffeine, and rosuvastatin in healthy human volunteers.

Conditions

  • NASH

Interventions

DRUG

Midazolam

Each subject will receive midazolam on Days 1 and 12.

DRUG

Caffeine

Each subject will receive caffeine on Days 1 and 12.

DRUG

Rosuvastatin

Each subject will receive rosuvastatin on Days 2 and 13.

DRUG

EDP-305

Each subject will receive EDP-305 on Days 5 through 15.

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Dickerson, MD · Pharmaceutical Research Associates

Study Design

Allocation
NA
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
2017-05-11
Primary Completion
2017-06-01
Completion
2017-06-14
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03187496 on ClinicalTrials.gov