Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/8/2017 |
| Start Date: | July 11, 2017 |
| End Date: | September 7, 2017 |
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin 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 itraconazole or rifampin on the pharmacokinetics
and safety of EDP-305 in healthy human volunteers.
the effect of concomitant administration of itraconazole or rifampin 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.
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