Status:
COMPLETED
Drug-Drug Interaction Study Between EDP-938, Itraconazole, Rifampin, and Quinidine in Healthy Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
Pharmaceutical Research Associates
Conditions:
RSV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
- 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
- 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.
Key Trial Info
Start Date :
November 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 27 2019
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT03755778
Start Date
November 29 2018
End Date
January 27 2019
Last Update
June 14 2019
Active Locations (1)
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1
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219