MedDataX Logo

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

NCT ID: NCT04498741

Last Updated: 2021-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-08

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

RSV Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

4-Part Single Group study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EDP-938 and tacrolimus interaction (Part 1)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)

Tacrolimus

Intervention Type DRUG

Subjects will receive tacrolimus once daily on Day 1 and Day 24

EDP-938 and dabigatran interaction (Part 2)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)

Dabigatran

Intervention Type DRUG

Subjects will receive dabigatran once daily on Day 1 and Day 13

EDP-938 and rosuvastatin interaction (Part 3)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)

Rosuvastatin

Intervention Type DRUG

Subjects will receive rosuvastatin once daily on Day 1 and Day 13

EDP-938 and midazolam interaction (Part 4)

Group Type EXPERIMENTAL

EDP-938

Intervention Type DRUG

Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)

Midazolam

Intervention Type DRUG

Subjects will receive midazolam once daily on Day 1 and Day 16

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EDP-938

Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)

Intervention Type DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)

Intervention Type DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)

Intervention Type DRUG

Tacrolimus

Subjects will receive tacrolimus once daily on Day 1 and Day 24

Intervention Type DRUG

Dabigatran

Subjects will receive dabigatran once daily on Day 1 and Day 13

Intervention Type DRUG

Rosuvastatin

Subjects will receive rosuvastatin once daily on Day 1 and Day 13

Intervention Type DRUG

EDP-938

Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)

Intervention Type DRUG

Midazolam

Subjects will receive midazolam once daily on Day 1 and Day 16

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pharmaceutical Research Associates

OTHER

Sponsor Role collaborator

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

EDP 938-006

Identifier Type: -

Identifier Source: org_study_id