RSV Infection
Conditions
Keywords
drug-drug interaction
Brief summary
A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of tacrolimus, dabigatran, rosuvastatin and midazolam on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
Interventions
DRUGEDP-938
Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)
DRUGTacrolimus
Subjects will receive tacrolimus once daily on Day 1 and Day 24
DRUGDabigatran
Subjects will receive dabigatran once daily on Day 1 and Day 13
DRUGRosuvastatin
Subjects will receive rosuvastatin once daily on Day 1 and Day 13
DRUGMidazolam
Subjects will receive midazolam once daily on Day 1 and Day 16
Sponsors
Pharmaceutical Research Associates
Enanta Pharmaceuticals, Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
4-Part Single Group study
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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. * For Part 1 subjects: * Clinical history or evidence at Screening consistent with hyperkalemia, hypertension and/or diabetes mellitus * For Part 2 Subjects: * Clinical history or evidence at screening of medically significant bleeding * History of a mechanical heart valve placement, a thromboembolic event or clinically significant thrombotic event, an autoimmune disease, eg, systemic lupus erythematosus (SLE), or recurrent spontaneous abortions * A platelet count \<LLN, or INR \>ULN, or aPTT \> ULN at Screening * Ongoing daily use of nonsteroidal anti-inflammatory drugs * For Part 3 subjects: * AST and/or ALT \>ULN at Screening * For Part 4 subjects: * History of glaucoma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC of midazolam with and without coadministration with EDP-938 | up to 17 days |
| Cmax of tacrolimus with and without coadministration with EDP-938 | up to 29 days |
| AUC of tacrolimus with and without coadministration with EDP-938 | up to 29 days |
| Cmax of dabigatran with and without coadministration with EDP-938 | up to 17 days |
| AUC of dabigatran with and without coadministration with EDP-938 | up to 17 days |
| Cmax of rosuvastatin with and without coadministration with EDP-938 | up to 17 days |
| AUC of rosuvastatin with and without coadministration with EDP-938 | up to 17 days |
| Cmax of midazolam with and without coadministration with EDP-938 | up to 17 days |
Secondary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | up to 34 days |
Countries
United States
Outcome results
None listed