Drug-Drug Interaction Study Between EDP-938, Cyclosporine and Prednisone in Healthy Adult Subjects

February 10, 2019 updated by: Enanta Pharmaceuticals, Inc

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Cyclosporine and Prednisone on the Pharmacokinetics and Safety of EDP-938 in Healthy Adult Subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Pharmaceutical Research Associates, Inc.,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EDP-938 and cyclosporine interaction (Part 1)
Drug: EDP-938
Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
Drug: EDP-938
Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
Drug: Cyclosporine
Subjects will receive one dose of cyclosporine on Day 5
EXPERIMENTAL: EDP-938 and prednisone interaction (Part 2)
Drug: EDP-938
Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
Drug: EDP-938
Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
Drug: Prednisone
Subjects will receive prednisone once daily from Day 5 to Day 14

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax of EDP-938 with and without coadministration with cyclosporine
Time Frame: Up to 12 days
Up to 12 days
AUC of EDP-938 with and without coadministration with cyclosporine
Time Frame: Up to 12 days
Up to 12 days
Cmax of EDP-938 with and without coadministration with prednisone
Time Frame: Up to 21 days
Up to 21 days
AUC of EDP-938 with and without coadministration with prednisone
Time Frame: Up to 21 days
Up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety measured by adverse events
Time Frame: Up to 21 days
Up to 21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 2, 2018

Primary Completion (ACTUAL)

November 17, 2018

Study Completion (ACTUAL)

December 13, 2018

Study Registration Dates

First Submitted

November 8, 2018

First Submitted That Met QC Criteria

November 20, 2018

First Posted (ACTUAL)

November 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 10, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP 938-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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