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

Primary Purpose

RSV Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EDP-938

Cyclosporine

Prednisone

About this trial

This is an interventional basic science trial for RSV Infection focused on measuring drug drug interaction study

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Pharmaceutical Research Associates, Inc.,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

EDP-938 and cyclosporine interaction (Part 1)

EDP-938 and prednisone interaction (Part 2)

Arm Description

Outcomes

Primary Outcome Measures

Cmax of EDP-938 with and without coadministration with cyclosporine

AUC of EDP-938 with and without coadministration with cyclosporine

Cmax of EDP-938 with and without coadministration with prednisone

AUC of EDP-938 with and without coadministration with prednisone

Secondary Outcome Measures

Safety measured by adverse events

Full Information

NCT ID

NCT03750383

First Posted

November 8, 2018

Last Updated

February 10, 2019

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

1. Study Identification

Unique Protocol Identification Number

NCT03750383

Brief Title

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

Official Title

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 Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

November 2, 2018 (Actual)

Primary Completion Date

November 17, 2018 (Actual)

Study Completion Date

December 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

RSV Infection

Keywords

drug drug interaction study

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Model Description

2-Part Single Group study

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDP-938 and cyclosporine interaction (Part 1)

Arm Type

Experimental

Arm Title

EDP-938 and prednisone interaction (Part 2)

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

EDP-938

Intervention Description

Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)

Intervention Type

Drug

Intervention Name(s)

EDP-938

Intervention Description

Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)

Intervention Type

Drug

Intervention Name(s)

Cyclosporine

Intervention Description

Subjects will receive one dose of cyclosporine on Day 5

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

Subjects will receive prednisone once daily from Day 5 to Day 14

Primary Outcome Measure Information:

Title

Cmax of EDP-938 with and without coadministration with cyclosporine

Time Frame

Up to 12 days

Title

AUC of EDP-938 with and without coadministration with cyclosporine

Time Frame

Up to 12 days

Title

Cmax of EDP-938 with and without coadministration with prednisone

Time Frame

Up to 21 days

Title

AUC of EDP-938 with and without coadministration with prednisone

Time Frame

Up to 21 days

Secondary Outcome Measure Information:

Title

Safety measured by adverse events

Time Frame

Up to 21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enanta Pharmaceuticals, Inc

Organizational Affiliation

Enanta Pharmaceuticals, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Pharmaceutical Research Associates, Inc.,

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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