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Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

intraconazole

Rifampin

EDP 305

About this trial

This is an interventional basic science trial for NASH - Nonalcoholic Steatohepatitis focused on measuring drug-drug interaction

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.
Female subjects must be of non-childbearing potential.

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

Part 1

Part 2

Arm Description

Outcomes

Primary Outcome Measures

Cmax of EDP-305 with and without coadministration with itraconazole

AUC of EDP-305 with and without coadministration with itraconazole

Cmax of EDP-305 with and without coadministration with rifampin

AUC of EDP-305 with and without coadministration with rifampin

Secondary Outcome Measures

Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).

Full Information

NCT ID

NCT03213145

First Posted

July 7, 2017

Last Updated

November 2, 2017

Sponsor

Enanta Pharmaceuticals, Inc

1. Study Identification

Unique Protocol Identification Number

NCT03213145

Brief Title

Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy Volunteers

Official Title

A Non-Randomized, Open-Label, Two-Part, Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics and Safety of EDP-305 in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

July 11, 2017 (Actual)

Primary Completion Date

August 10, 2017 (Actual)

Study Completion Date

September 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

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

This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.

6. Conditions and Keywords

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

NASH - Nonalcoholic Steatohepatitis

Keywords

drug-drug interaction

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

Part 1

Arm Type

Experimental

Arm Title

Part 2

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

intraconazole

Intervention Description

Subjects will receive itraconazole once daily from Day 5 through Day18

Intervention Type

Drug

Intervention Name(s)

Rifampin

Intervention Description

Subjects will receive rifampin once daily from Day 5 through Day 16

Intervention Type

Drug

Intervention Name(s)

EDP 305

Intervention Description

Subjects will receive EDP 305 once daily on Day 1 and Day 14

Primary Outcome Measure Information:

Title

Cmax of EDP-305 with and without coadministration with itraconazole

Time Frame

Up to 19 days

Title

AUC of EDP-305 with and without coadministration with itraconazole

Time Frame

Up to 19 days

Title

Cmax of EDP-305 with and without coadministration with rifampin

Time Frame

Up to 17 days

Title

AUC of EDP-305 with and without coadministration with rifampin

Time Frame

Up to 17 days

Secondary Outcome Measure Information:

Title

Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).

Time Frame

Up to 19 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. Female subjects must be of non-childbearing potential. 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, Ind

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-305, Intraconazole and Rifampin in Healthy Volunteers

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