Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers
Phase 1
Completed
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Registration Number
- NCT03213145
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part 2 EDP 305 - Part 2 Rifampin - Part 1 intraconazole - Part 1 EDP 305 -
- Primary Outcome Measures
Name Time Method Cmax of EDP-305 with and without coadministration with itraconazole Up to 19 days Cmax of EDP-305 with and without coadministration with rifampin Up to 17 days AUC of EDP-305 with and without coadministration with itraconazole Up to 19 days AUC of EDP-305 with and without coadministration with rifampin Up to 17 days
- Secondary Outcome Measures
Name Time Method Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). Up to 19 days
Trial Locations
- Locations (1)
Pharmaceutical Research Associates, Inc.,
🇺🇸Lenexa, Kansas, United States