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EDP-235 and Carbamazepine interaction (Part 2) for Coronavirus

Phase 1
Waitlist Available
Research Sponsored by Enanta Pharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 26
Awards & highlights

Study Summary

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Carbamazepine
Itraconazole
AUC of EDP-235 with and without coadministration with Quinidine
+3 more
Secondary outcome measures
Safety measured by adverse events

Trial Design

3Treatment groups
Experimental Treatment
Group I: EDP-235 and Itraconazole interaction (Part 1)Experimental Treatment2 Interventions
Subjects will receive EDP-235 and Itraconazole on respective dosing days
Group II: EDP-235 and Carbamazepine interaction (Part 2)Experimental Treatment2 Interventions
Subjects will receive EDP-235 and Carbamazepine on respective dosing days
Group III: EDP and Quinidine interaction (Part 3)Experimental Treatment2 Interventions
Subjects will receive EDP-235 and Quinidine on respective dosing days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EDP-235
2022
Completed Phase 1
~140
Itraconazole
2017
Completed Phase 2
~780
Carbamazepine
2016
Completed Phase 4
~2690
Quinidine
2012
Completed Phase 1
~610

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Enanta Pharmaceuticals, IncLead Sponsor
39 Previous Clinical Trials
2,948 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.
2022. "Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05594602.
~14 spots leftby Apr 2025
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