Status:
COMPLETED
Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
Pharmaceutical Research Associates
Conditions:
RSV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 Hea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT04498741
Start Date
July 8 2020
End Date
June 1 2021
Last Update
October 13 2021
Active Locations (1)
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1
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219