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A Study of EDP-297 in Healthy Subjects

Primary Purpose

NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

EDP-297

Placebo

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis focused on measuring "First-in-Human", Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer

Eligibility Criteria

18 Years - 65 Years (Adult, Older 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 65 years, inclusive.

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 -2.
Current tobacco smokers or use of tobacco within 1 months prior to screening.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening.
Participation in a clinical trial within 30 days prior to the first dose of study drug.

Sites / Locations

PRA Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

EDP-297 SAD Cohorts

EDP-297 MAD Cohorts

EDP-297 SAD Placebo Cohort

EDP-297 MAD Placebo Cohort

Arm Description

EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration

EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days

Matching placebo, oral solution, once daily in one single administration

Matching placebo, oral solution, once daily for 14 days

Outcomes

Primary Outcome Measures

Safety measured by adverse events

Secondary Outcome Measures

Cmax of EDP-297

AUC of EDP-297

Full Information

NCT ID

NCT04559126

First Posted

September 10, 2020

Last Updated

October 27, 2021

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

PRA Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04559126

Brief Title

A Study of EDP-297 in Healthy Subjects

Official Title

A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-297 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD), and the Effect of Food on EDP-297 Pharmacokinetics in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

June 21, 2021 (Actual)

Study Completion Date

June 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

PRA Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-297 in healthy adult subjects.

Detailed Description

The first phase assesses single ascending doses of EDP-297 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses of EDP-297 or placebo for 14-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-297 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-297 or placebo

6. Conditions and Keywords

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

NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Keywords

"First-in-Human", Single Ascending Dose, Multiple Ascending Dose, Healthy Volunteer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDP-297 SAD Cohorts

Arm Type

Experimental

Arm Description

EDP-297 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 oral solution, once daily in one single administration

Arm Title

EDP-297 MAD Cohorts

Arm Type

Experimental

Arm Description

EDP-297 Dose 1, Dose 2 and Dose 3 oral solution, once daily for 14 days

Arm Title

EDP-297 SAD Placebo Cohort

Arm Type

Placebo Comparator

Arm Description

Matching placebo, oral solution, once daily in one single administration

Arm Title

EDP-297 MAD Placebo Cohort

Arm Type

Placebo Comparator

Arm Description

Matching placebo, oral solution, once daily for 14 days

Intervention Type

Drug

Intervention Name(s)

EDP-297

Intervention Description

EDP-297 Oral solution

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo to match EDP-297

Primary Outcome Measure Information:

Title

Safety measured by adverse events

Time Frame

Up to 8 Days in SAD Cohorts

Title

Safety measured by adverse events

Time Frame

Up to 21 Days in MAD Cohorts

Secondary Outcome Measure Information:

Title

Cmax of EDP-297

Time Frame

Up to 6 Days in SAD Cohorts

Title

Cmax of EDP-297

Time Frame

Up to 18 Days in MAD Cohorts

Title

AUC of EDP-297

Time Frame

Up to 6 Days in SAD Cohorts

Title

AUC of EDP-297

Time Frame

Up to 18 Days in MAD Cohorts

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 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 65 years, inclusive. 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 -2. Current tobacco smokers or use of tobacco within 1 months prior to screening. Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). History of regular alcohol consumption exceeding 14 drinks/week for females and 21 drinks/week for males within 6 months of Screening. 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

PRA Health Sciences

City

Groningen

ZIP/Postal Code

9728 NZ

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

A Study of EDP-297 in Healthy Subjects

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