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

COVID-19 Clinical Trial

Official title:

A NON-RANDOMIZED, OPEN-LABEL, THREE-PART, DRUG-DRUG INTERACTION STUDY TO EVALUATE THE EFFECTS OF ITRACONAZOLE, CARBAMAZEPINE, AND QUINIDINE ON THE PHARMACOKINETICS AND SAFETY OF EDP-235 IN HEALTHY PARTICIPANTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05594602
• Other study ID #: EDP 235-002
• Status: Completed
• Phase: Phase 1
• Start date: October 6, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: April 2023
• Source: Enanta Pharmaceuticals, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 30, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

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 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)

• History of unexplained syncope, structural heart disease, or clinically significant arrhythmias

• Personal or family history of long QT syndrome (genetically proven or suggested by sudden death of a close relative due to cardiac causes at a young age) or Brugada syndrome

• PR interval >220 ms or any 2nd or 3rd degree AV block

• Ventricular pre-excitation

• History of drug allergy to itraconazole or other azole antifungals; history of drug allergy to carbamazepine or carboxamide derivatives [e.g. oxcarbazepine]; known hypersensitivity to drugs structurally related to carbamazepine [e.g.: tricyclic antidepressants] or any of its excipients);history or known hypersensitivity to mefloquine, quinine, or quinidine

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• EDP-235
Subjects will receive EDP-235 on Days 1 and 14
• EDP-235
Subjects will receive EDP-235 on Days 1 and 23
• EDP-235
Subjects will receive EDP-235 on Days 1 and 8
• Itraconazole
Subjects will receive itraconazole QD Days 5-18
• Carbamazepine
Subjects will receive carbamazepine BID Days 5-23 and Days 24-27
• Quinidine
Subjects will receive quinidine BID Days 5-12

Locations

Country	Name	City	State
United States	ICON, plc.	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of EDP-235 with and without coadministration with Itraconazole		Day 1 through Day 19
Primary	AUC of EDP-235 with and without coadministration with Itraconazole		Day 1 through Day 19
Primary	Cmax of EDP-235 with and without coadministration with Carbamazepine		Day 1 through Day 26
Primary	AUC of EDP-235 with and without coadministration with Carbamazepine		Day 1 through Day 26
Primary	Cmax of EDP-235 with and without coadministration with Quinidine		Day 1 through Day 13
Primary	AUC of EDP-235 with and without coadministration with Quinidine		Day 1 through Day 13
Secondary	Safety measured by adverse events		Up to 34 days