Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Respiratory Syncytial Virus (Rsv)
Treatment
Quinidine
EDP-323
carbamazepine
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 65years, 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 ofcontraception from the date of Screening until 30 days after the last dose ofEDP-323. A male participant who has not had a vasectomy and is sexually active witha woman of childbearing potential must agree to use effective contraception from thedate of Screening to 90 days after his last dose of study drug.
Exclusion
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 orsubjects 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 studydrug
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 significantarrhythmias
Personal or family history of long QT syndrome (genetically proven or suggested bysudden death of a close relative due to cardiac causes at a young age) or Brugadasyndrome
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, dueto reported incidence of agranulocytosis and aplastic anemia with carbamazepine
Study Design
Connect with a study center
ICON, plc
San Antonio, Texas 78209
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.