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

• Status: Completed
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Enanta Pharmaceuticals
• Collaborator: Pharmaceutical Research Associates
• Treatments: Dabigatran; Midazolam; Rosuvastatin Calcium; Tacrolimus

Criteria

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 countULN, 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