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

NCT05594602 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-04-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

EDP-235

Subjects will receive EDP-235 on Days 1 and 14

DRUG

EDP-235

Subjects will receive EDP-235 on Days 1 and 23

DRUG

EDP-235

Subjects will receive EDP-235 on Days 1 and 8

DRUG

Itraconazole

Subjects will receive itraconazole QD Days 5-18

DRUG

Carbamazepine

Subjects will receive carbamazepine BID Days 5-23 and Days 24-27

DRUG

Quinidine

Subjects will receive quinidine BID Days 5-12

Sponsors & Collaborators

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-06
Primary Completion
2022-12-14
Completion
2022-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05594602 on ClinicalTrials.gov