Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects
- Registration Number
- NCT03750383
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects
- 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.
- 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 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 EDP-938 and cyclosporine interaction (Part 1) EDP-938 - EDP-938 and cyclosporine interaction (Part 1) Cyclosporine - EDP-938 and prednisone interaction (Part 2) Prednisone - EDP-938 and prednisone interaction (Part 2) EDP-938 -
- Primary Outcome Measures
Name Time Method AUC of EDP-938 with and without coadministration with prednisone Up to 21 days Cmax of EDP-938 with and without coadministration with prednisone Up to 21 days Cmax of EDP-938 with and without coadministration with cyclosporine Up to 12 days AUC of EDP-938 with and without coadministration with cyclosporine Up to 12 days
- Secondary Outcome Measures
Name Time Method Safety measured by adverse events Up to 21 days
Trial Locations
- Locations (1)
Pharmaceutical Research Associates, Inc.,
🇺🇸Lenexa, Kansas, United States