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

A Non-Randomized, Multiple-Dose, Open-Label, Single Sequence Study to Evaluate the Effect of Concomitant Administration of EDP-305 on the Pharmacokinetics and Safety of Midazolam, Caffeine, and Rosuvastatin in Healthy Human Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03187496

Enrollment

Registered

2017-06-15

Start date

2017-05-11

Completion date

2017-06-14

Last updated

2017-08-21

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

Conditions

NASH

Keywords

drug-drug interaction

Brief 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.

Interventions

DRUGMidazolam

Each subject will receive midazolam on Days 1 and 12.

DRUGCaffeine

Each subject will receive caffeine on Days 1 and 12.

DRUGRosuvastatin

Each subject will receive rosuvastatin on Days 2 and 13.

DRUGEDP-305

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

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. * Female subjects must be of non-childbearing potential.

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 midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.	Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days

Secondary

Measure	Time frame
Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
t1/2 of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.	Up to 17 days
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).	Up to 17 days
Vd/F of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days
AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days

Countries

United States

Outcome results

None listed

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