Clinical trial NCT04498741: Drug-Drug Interaction Study Between EDP-938, Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
Official title: A Non-Randomized, Open-Label, Three-Part, Drug-Drug Interaction Study to Evaluate the Effects of EDP-938 on the Pharmacokinetics of Tacrolimus, Dabigatran, Rosuvastatin and Midazolam in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: RSV Infection
Keywords: drug-drug interaction
Lead sponsor: Enanta Pharmaceuticals, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaceutical Research Associates
First posted: 2020-08-04
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 4-Part Single Group study
Primary purpose: BASIC_SCIENCE

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


Eligibility 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 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

Primary outcomes:
measure: Cmax of tacrolimus with and without coadministration with EDP-938
timeFrame: up to 29 days
measure: AUC of tacrolimus with and without coadministration with EDP-938
timeFrame: up to 29 days
measure: Cmax of dabigatran with and without coadministration with EDP-938
timeFrame: up to 17 days
measure: AUC of dabigatran with and without coadministration with EDP-938
timeFrame: up to 17 days
measure: Cmax of rosuvastatin with and without coadministration with EDP-938
timeFrame: up to 17 days
measure: AUC of rosuvastatin with and without coadministration with EDP-938
timeFrame: up to 17 days
measure: Cmax of midazolam with and without coadministration with EDP-938
timeFrame: up to 17 days
measure: AUC of midazolam with and without coadministration with EDP-938
timeFrame: up to 17 days
Secondary outcomes:
measure: Safety measured by adverse events
timeFrame: up to 34 days
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pharmaceutical Research Associates, Inc.,
state: Kansas
Study officials:
affiliation: Enanta Pharmaceuticals, Inc
name: Enanta Pharmaceuticals, Inc
role: STUDY_DIRECTOR
References: