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A Study of EDP-297 in Healthy Subjects

NCT ID: NCT04559126

Last Updated: 2021-10-29

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2021-06-21

Brief Summary

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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

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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

Conditions

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NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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EDP-297 SAD Cohorts

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

Group Type EXPERIMENTAL

EDP-297

Intervention Type DRUG

EDP-297 Oral solution

EDP-297 MAD Cohorts

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

Group Type EXPERIMENTAL

EDP-297

Intervention Type DRUG

EDP-297 Oral solution

EDP-297 SAD Placebo Cohort

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo to match EDP-297

EDP-297 MAD Placebo Cohort

Matching placebo, oral solution, once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo to match EDP-297

Interventions

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EDP-297

EDP-297 Oral solution

Intervention Type DRUG

Placebo

placebo to match EDP-297

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PRA Health Sciences

INDUSTRY

Sponsor Role collaborator

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

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PRA Health Sciences

Groningen, , Netherlands

Site Status

Countries

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Netherlands

References

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Marotta C, Ahmad A, Luo E, Oosterhaven J, van Marle S, Adda N. EDP-297: A novel, farnesoid X receptor agonist-Results of a phase I study in healthy subjects. Clin Transl Sci. 2023 Feb;16(2):338-351. doi: 10.1111/cts.13453. Epub 2022 Nov 21.

Reference Type DERIVED
PMID: 36369848 (View on PubMed)

Other Identifiers

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EDP 297-001

Identifier Type: -

Identifier Source: org_study_id