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

NCT ID: NCT05594615

Last Updated: 2023-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-06
• Study Completion Date: 2022-11-18

Brief Summary

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

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EDP-235, midazolam, rosuvastatin and caffeine

Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days

Group Type: EXPERIMENTAL

EDP-235

Intervention Type: DRUG

Subjects will receive EDP-235 once daily on Days 5-15

Midazolam

Intervention Type: DRUG

Subjects will receive midazolam once daily on Days 1 and 12

Rosuvastatin

Intervention Type: DRUG

Subjects will receive rosuvastatin once daily on Days 2 and 13

Caffeine

Intervention Type: DRUG

Subjects will receive caffeine once daily on Days 1 and 12

Interventions

EDP-235

Subjects will receive EDP-235 once daily on Days 5-15

Intervention Type: DRUG

Midazolam

Subjects will receive midazolam once daily on Days 1 and 12

Intervention Type: DRUG

Rosuvastatin

Subjects will receive rosuvastatin once daily on Days 2 and 13

Intervention Type: DRUG

Caffeine

Subjects will receive caffeine once daily on Days 1 and 12

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

ICON, plc.

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

EDP 235-003

Identifier Type: -

Identifier Source: org_study_id