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

NCT04783753 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 514-003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis B

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (6)

• Cmax of EDP-514 with and without coadministration with itraconazole

  up to 19 days

• AUC of EDP-514 with and without coadministration with itraconazole

  19 days

• Cmax of EDP-514 with and without coadministration with carbamazepine

  up to 28 days

• AUC of EDP-514 with and without coadministration with carbamazepine

  up to 28 days

• Cmax of EDP-514 with and without coadministration with quinidine

  up to 13 days

• AUC of EDP-514 with and without coadministration with quinidine

  up to 13 days

Secondary Outcomes (1)

• Safety measured by adverse events

  up to 34 days

Study Arms (3)

EDP-514 and Itraconazole interaction (Part 1)

EXPERIMENTAL

Drug: EDP-514; Drug: Itraconazole

EDP-514 and Carbamazepine interaction (Part 2)

EXPERIMENTAL

Drug: EDP-514; Drug: Carbamazepin

EDP-514 and Quinidine interaction (Part 3)

EXPERIMENTAL

Drug: EDP-514; Drug: Quinidine

Interventions

EDP-514 DRUG

Subjects will receive EDP-514 on Days 1 and 14

EDP-514 and Itraconazole interaction (Part 1)

Itraconazole DRUG

Subjects will receive itraconazole QD for 14 days

EDP-514 and Itraconazole interaction (Part 1)

Carbamazepin DRUG

Subjects will receive carbamazepine BID for 23 days

EDP-514 and Carbamazepine interaction (Part 2)

Quinidine DRUG

Subjects will receive quinidine BID for 8 days

EDP-514 and Quinidine interaction (Part 3)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• PRA Health Sciences: collaborator

Study Sites (1)

Pharmaceutical Research Association

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Itraconazole; Carbamazepine; Quinidine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Cinchona Alkaloids; Alkaloids; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Quinolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: November 5, 2020
• Primary Completion: June 28, 2021
• Study Completion: July 9, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)