Drug-drug Interaction Study Between EDP-305, Fluconazole and Quinidine in Healthy Volunteers
Status: | Completed |
---|---|
Conditions: | Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 12/7/2018 |
Start Date: | July 19, 2018 |
End Date: | August 21, 2018 |
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole and Quinidine on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers
This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate
the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics
and safety of EDP-305 in healthy human volunteers.
the effect of concomitant administration of fluconazole or quinidine on the pharmacokinetics
and safety of EDP-305 in healthy human 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 55
years, inclusive.
- Female subjects must be of non-childbearing potential.
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.
- Participation in a clinical trial within 30 days prior to the first dose of study
drug.
- Clinically significant electrocardiogram abnormalities or QTcF greater than 450 ms for
males and 470 ms for females at either Screening or Day -1 (Part 2 only), or any prior
history of QT abnormality.
- For Part 2 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
We found this trial at
1
site
Salt Lake City, Utah 32751
Principal Investigator: Ahad A Sabet, MD
Phone: 913-410-2258
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