Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects

This is an interventional basic science trial for RSV Infection focused on measuring drug-drug interaction Read More

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