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

NCT05594602 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP 235-002
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Keywords

drug-drug interaction

Outcome Measures

Primary Outcomes (6)

• Cmax of EDP-235 with and without coadministration with Itraconazole

  Day 1 through Day 19

• AUC of EDP-235 with and without coadministration with Itraconazole

  Day 1 through Day 19

• Cmax of EDP-235 with and without coadministration with Carbamazepine

  Day 1 through Day 26

• AUC of EDP-235 with and without coadministration with Carbamazepine

  Day 1 through Day 26

• Cmax of EDP-235 with and without coadministration with Quinidine

  Day 1 through Day 13

• AUC of EDP-235 with and without coadministration with Quinidine

  Day 1 through Day 13

Secondary Outcomes (1)

• Safety measured by adverse events

  Up to 34 days

Study Arms (3)

EDP-235 and Itraconazole interaction (Part 1)

EXPERIMENTAL

Subjects will receive EDP-235 and Itraconazole on respective dosing days

Drug: EDP-235; Drug: Itraconazole

EDP-235 and Carbamazepine interaction (Part 2)

EXPERIMENTAL

Subjects will receive EDP-235 and Carbamazepine on respective dosing days

Drug: EDP-235; Drug: Carbamazepine

EDP and Quinidine interaction (Part 3)

EXPERIMENTAL

Subjects will receive EDP-235 and Quinidine on respective dosing days

Drug: EDP-235; Drug: Quinidine

Interventions

EDP-235 DRUG

Subjects will receive EDP-235 on Days 1 and 14

EDP-235 and Itraconazole interaction (Part 1)

Itraconazole DRUG

Subjects will receive itraconazole QD Days 5-18

EDP-235 and Itraconazole interaction (Part 1)

Carbamazepine DRUG

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

EDP-235 and Carbamazepine interaction (Part 2)

Quinidine DRUG

Subjects will receive quinidine BID Days 5-12

EDP 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
• 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.

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 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
• Platelets, white blood cell count or hemoglobin below the lower limit of normal, due to reported incidence of agranulocytosis and aplastic anemia with carbamazepine.
• For Part 2 and Part 3 participants, the following cardiovascular abnormalities:
• QRS duration \>110 ms
• Incomplete right bundle branch block or any complete bundle branch block
• Heart rate \<40 or \>90 beats per minute (per vital sign capture while rested)

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

ICON, plc.

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

EDP-235; Itraconazole; Carbamazepine; Quinidine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract 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: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 26, 2022
• Study Start: October 6, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 30, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

US (1)