Clinical trial NCT04783753: Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects
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-514 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatitis B
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2021-03-05
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cmax of EDP-514 with and without coadministration with itraconazole
timeFrame: up to 19 days
measure: AUC of EDP-514 with and without coadministration with itraconazole
timeFrame: 19 days
measure: Cmax of EDP-514 with and without coadministration with carbamazepine
timeFrame: up to 28 days
measure: AUC of EDP-514 with and without coadministration with carbamazepine
timeFrame: up to 28 days
measure: Cmax of EDP-514 with and without coadministration with quinidine
timeFrame: up to 13 days
measure: AUC of EDP-514 with and without coadministration with quinidine
timeFrame: up to 13 days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: up to 34 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Association
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: