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

COVID-19 Clinical Trial

Official title:

A NON-RANDOMIZED, MULTIPLE-DOSE, OPEN-LABEL, SINGLE SEQUENCE STUDY TO EVALUATE THE EFFECT OF CONCOMITANT ADMINISTRATION OF EDP-235 ON THE PHARMACOKINETICS AND SAFETY OF MIDAZOLAM, CAFFEINE, AND ROSUVASTATIN IN HEALTHY PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594615
• Other study ID #: EDP 235-003
• Status: Completed
• Phase: Phase 1
• Start date: October 6, 2022
• Est. completion date: November 18, 2022

Study information

• Verified date: April 2023
• Source: Enanta Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 18, 2022
• Est. primary completion date: November 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• EDP-235
Subjects will receive EDP-235 once daily on Days 5-15
• Midazolam
Subjects will receive midazolam once daily on Days 1 and 12
• Rosuvastatin
Subjects will receive rosuvastatin once daily on Days 2 and 13
• Caffeine
Subjects will receive caffeine once daily on Days 1 and 12

Locations

Country	Name	City	State
United States	ICON, plc.	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235		Up to 17 Days
Primary	AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235		Up to 17 Days
Secondary	Safety measured by adverse events		Up to 22 days