Drug-Drug Interaction Study Between EDP-235, Midazolam, Caffeine and Rosuvastatin in Healthy Subjects

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Drug: EDP-235; Drug: Midazolam; Drug: Rosuvastatin; Drug: Caffeine

• Registration Number: NCT05594615
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief Summary

A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-06
• Study First Submitted: 2022-10-21
• Study First Submitted QC: 2022-10-21
• Study First Posted: 2022-10-26
• Primary Completion: 2022-11-04
• Study Completion: 2022-11-18
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

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
• 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-235. A male participant who has not had a vasectomy and is sexually active with a woman of childbearing potential must agree to use effective contraception from the date of Screening to 90 days after his last dose of study drug.

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
• History of drug allergy to midazolam, caffeine, or rosuvastatin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EDP-235, midazolam, rosuvastatin and caffeine	Midazolam	Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days
EDP-235, midazolam, rosuvastatin and caffeine	Caffeine	Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days
EDP-235, midazolam, rosuvastatin and caffeine	EDP-235	Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days
EDP-235, midazolam, rosuvastatin and caffeine	Rosuvastatin	Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days

Primary Outcome Measures

Name	Time	Method
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235	Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235	Up to 17 Days

Secondary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Up to 22 days

Trial Locations

Locations (1)

ICON, plc.; 🇺🇸 Salt Lake City, Utah, United States