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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2018-12-13

Brief Summary

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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

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Detailed Description

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Conditions

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RSV Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

2-Part Single Group study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EDP-938 and cyclosporine interaction (Part 1)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

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

Cyclosporine

Intervention Type DRUG

Subjects will receive one dose of cyclosporine on Day 5

EDP-938 and prednisone interaction (Part 2)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

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

Prednisone

Intervention Type DRUG

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

Interventions

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EDP-938

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

Intervention Type DRUG

EDP-938

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

Intervention Type DRUG

Cyclosporine

Subjects will receive one dose of cyclosporine on Day 5

Intervention Type DRUG

Prednisone

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes