Clinical trial NCT03755778: Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
Official title: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2018-11-28
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
Intervention model description: 3-Part Single Group study
Primary purpose: BASIC_SCIENCE

Brief summary: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Rifampin, and Quinidine on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects


Eligibility criteria: 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 938.

Exclusion Criteria:

* Clinically relevant evidence or history of illness or disease.
* For Part 3 subjects, 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
* 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.

Primary outcomes:
measure: Cmax of EDP-938 with and without coadministration with itraconazole
timeFrame: Up to 19 days
measure: AUC of EDP-938 with and without coadministration with itraconazole
timeFrame: Up to 19 days
measure: Cmax of EDP-938 with and without coadministration with rifampin
timeFrame: Up to 17 days
measure: AUC of EDP-938 with and without coadministration with rifampin
timeFrame: Up to 17 days
measure: Cmax of EDP-938 with and without coadministration with quinidine
timeFrame: Up to 13 days
measure: AUC of EDP-938 with and without coadministration with quinidine
timeFrame: Up to 13 days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: Up to 25 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals
role: STUDY_DIRECTOR
References: