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

NCT05594615 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 235-003
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Safety measured by adverse events

  Up to 22 days

Study Arms (1)

EDP-235, midazolam, rosuvastatin and caffeine

EXPERIMENTAL

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

Drug: EDP-235; Drug: Midazolam; Drug: Rosuvastatin; Drug: Caffeine

Interventions

EDP-235 DRUG

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

EDP-235, midazolam, rosuvastatin and caffeine

Midazolam DRUG

Subjects will receive midazolam once daily on Days 1 and 12

EDP-235, midazolam, rosuvastatin and caffeine

Rosuvastatin DRUG

Subjects will receive rosuvastatin once daily on Days 2 and 13

EDP-235, midazolam, rosuvastatin and caffeine

Caffeine DRUG

Subjects will receive caffeine once daily on Days 1 and 12

EDP-235, midazolam, rosuvastatin and caffeine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

ICON, plc.

Salt Lake City, Utah, 84124, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

EDP-235; Midazolam; Rosuvastatin Calcium; Caffeine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Xanthines; Alkaloids; Purinones; Purines

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: October 6, 2022
• Primary Completion: November 4, 2022
• Study Completion: November 18, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)