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Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects. | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS

NCT05594602•Enanta Pharmaceuticals, Inc

View on ClinicalTrials.gov

Summary

A Drug-Drug Interaction study to assess the effects of itraconazole, carbamazepine and quinidine on the Pharmacokinetics and Safety of EDP-235.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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
•For Part 2 participants:
•* Participants of Asian ancestry, given association of carbamazepine and severe rash (Stevens-Johnson Syndrome \[SJS and Toxic Epidermal Necrolysis \[TEN\]) with HLA-B 1502 in this population
+10 more criteria

Locations (1)

ICON, plc.

Lenexa, Kansas, United States

Key Dates

Start Date

October 6, 2022

Primary Completion Date

December 14, 2022

Completion Date

December 30, 2022

Last Updated

April 27, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

EDP-235

DRUG

EDP-235

DRUG

EDP-235

DRUG

Itraconazole

DRUG

Carbamazepine

DRUG

Quinidine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 27, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

Inclusion Criteria

Exclusion Criteria

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