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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03750383

Enrollment

Registered

2018-11-23

Start date

2018-11-02

Completion date

2018-12-13

Last updated

2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

RSV Infection

Keywords

drug drug interaction study

Brief 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

Interventions

DRUGEDP-938

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

DRUGCyclosporine

Subjects will receive one dose of cyclosporine on Day 5

DRUGPrednisone

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

2-Part Single Group study

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Cmax of EDP-938 with and without coadministration with cyclosporine	Up to 12 days
AUC of EDP-938 with and without coadministration with cyclosporine	Up to 12 days
Cmax of EDP-938 with and without coadministration with prednisone	Up to 21 days
AUC of EDP-938 with and without coadministration with prednisone	Up to 21 days

Secondary

Measure	Time frame
Safety measured by adverse events	Up to 21 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026