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

Phase 1

Completed

• Conditions: NASH
• Interventions: Drug: Midazolam; Drug: Caffeine; Drug: Rosuvastatin; Drug: EDP-305

• Registration Number: NCT03187496
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-11
• Primary Completion: 2017-06-01
• Study First Submitted: 2017-06-01
• Study First Submitted QC: 2017-06-12
• Study Completion: 2017-06-14
• Study First Posted: 2017-06-15
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Midazolam	-
Single Arm	EDP-305	-
Single Arm	Caffeine	-
Single Arm	Rosuvastatin	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 ratios for 1'-hydroxymidazolam/midazolam, paraxanthine/caffeine, and N-desmethyl-rosuvastatin/rosuvastatin.	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
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
Cmax of 1'-hydroxymidazolam, paraxanthine 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
Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.	Up to 17 days

Trial Locations

Locations (1)

Pharmaceutical Research Associates, Inc.,; 🇺🇸 Lenexa, Kansas, United States