Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2021-07-09

Brief Summary

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Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

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Detailed Description

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Conditions

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Hepatitis B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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EDP-514 and Itraconazole interaction (Part 1)

Group Type EXPERIMENTAL

EDP-514

Intervention Type DRUG

Subjects will receive EDP-514 on Days 1 and 14

Itraconazole

Intervention Type DRUG

Subjects will receive itraconazole QD for 14 days

EDP-514 and Carbamazepine interaction (Part 2)

Group Type EXPERIMENTAL

EDP-514

Intervention Type DRUG

Subjects will receive EDP-514 on Days 1 and 23

Carbamazepin

Intervention Type DRUG

Subjects will receive carbamazepine BID for 23 days

EDP-514 and Quinidine interaction (Part 3)

Group Type EXPERIMENTAL

EDP-514

Intervention Type DRUG

Subjects will receive EDP-514 on Days 1 and 8

Quinidine

Intervention Type DRUG

Subjects will receive quinidine BID for 8 days

Interventions

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EDP-514

Subjects will receive EDP-514 on Days 1 and 14

Intervention Type DRUG

EDP-514

Subjects will receive EDP-514 on Days 1 and 23

Intervention Type DRUG

EDP-514

Subjects will receive EDP-514 on Days 1 and 8

Intervention Type DRUG

Itraconazole

Subjects will receive itraconazole QD for 14 days

Intervention Type DRUG

Carbamazepin

Subjects will receive carbamazepine BID for 23 days

Intervention Type DRUG

Quinidine

Subjects will receive quinidine BID for 8 days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* An informed consent document signed and dated by the subject.
* Male and female subjects of any ethnic origin between the ages of 18 and 55 years, inclusive
* Female subjects who are heterosexually active and of childbearing potential must agree to use two effective methods of contraception from the date of Screening until 30 days after the last dose of EDP-514.
* Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of 50 kg.

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 clinically significant active infection.
* A positive urine drug screen at Screening or Day -1.
* Current tobacco smokers or use of tobacco products within 3 months prior to Screening.
* Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).

• Clinically significant laboratory abnormalities at screening or Day -1, as determined by the Investigator (including but not limited to hypokalemia, hypocalcemia, or hypomagnesemia for Part 3 participants).
* History of regular alcohol consumption
* Participation in a clinical trial within 30 days prior to the first dose of study drug.

For Part 2 (Carbamazepine) 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.
* Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes