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

Enanta Pharmaceuticals, Inc24 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

NASH

Interventions

MidazolamDRUG

Each subject will receive midazolam on Days 1 and 12.

CaffeineDRUG

Each subject will receive caffeine on Days 1 and 12.

RosuvastatinDRUG

Each subject will receive rosuvastatin on Days 2 and 13.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, United States

Outcomes

Primary Outcomes

Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

Time frame: Up to 17 Days

AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.

Time frame: Up to 17 days

Secondary Outcomes

Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

Time frame: Up to 17 days

AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

Time frame: Up to 17 days

Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.

Time frame: 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.

Time frame: Up to 17 days

CL/F of midazolam, caffeine and rosuvastatin with and without the coadministration of EDP-305.

Time frame: 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.

Time frame: Up to 17 days

AUC ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.

Time frame: Up to 17 days

Data from ClinicalTrials.gov

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