A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: RSV Infection; Drug Drug Interaction (DDI)

Treatments: Drug: Itraconazole; Drug: EDP-323; Drug: fluconazole; Drug: Quinidine; Drug: carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06847464

EDP 323-005

Details and patient eligibility

About

The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 65 years, inclusive.
• Screening body mass index (BMI) of 18 to 30 kg/m2 with a minimum body weight of50 kg
• Female subjects 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-323. 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 exceeding protocol limits
• Participation in a clinical trial within 28 days prior to the first dose of study drug
• 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
• Other exclusions for Part 2 (carbamazepine) participants
• Participants of Asian ancestry with HLA allele 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

EDP-323 and itraconazole interaction (Part 1)

Experimental group

Description:

Subjects will receive EDP-323 and itraconazole on respective dosing days

Treatment:

Drug: EDP-323

Drug: EDP-323

Drug: EDP-323

Drug: EDP-323

Drug: Itraconazole

EDP-323 and carbamazepine interaction (Part 2)

Experimental group

Description:

Subjects will receive EDP-323 and carbamazepine on respective dosing days

Treatment:

Drug: EDP-323

Drug: carbamazepine

Drug: EDP-323

Drug: EDP-323

Drug: EDP-323

EDP-323 and quinidine interaction (Part 3)

Experimental group

Description:

Subjects will receive EDP-323 and quinidine on respective dosing days

Treatment:

Drug: EDP-323

Drug: Quinidine

Drug: EDP-323

Drug: EDP-323

Drug: EDP-323

EDP-323 and fluconazole interaction (Part 4)

Experimental group

Description:

Subjects will receive EDP-323 and fluconazole on respective dosing days

Treatment:

Drug: EDP-323

Drug: EDP-323

Drug: fluconazole

Drug: EDP-323

Drug: EDP-323