A Study of EDP-297 in Healthy Subjects

NCT04559126 | Completed Phase 1

• 1 other identifier: EDP 297-001
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety measured by adverse events

  Up to 8 Days in SAD Cohorts

• Safety measured by adverse events

  Up to 21 Days in MAD Cohorts

Secondary Outcomes (4)

• Cmax of EDP-297

  Up to 6 Days in SAD Cohorts

• Cmax of EDP-297

  Up to 18 Days in MAD Cohorts

• AUC of EDP-297

  Up to 6 Days in SAD Cohorts

• AUC of EDP-297

  Up to 18 Days in MAD Cohorts

Study Arms (4)

EDP-297 SAD Cohorts

EXPERIMENTAL

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

Drug: EDP-297

EDP-297 MAD Cohorts

EXPERIMENTAL

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

Drug: EDP-297

EDP-297 SAD Placebo Cohort

PLACEBO COMPARATOR

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

Drug: Placebo

EDP-297 MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, oral solution, once daily for 14 days

Drug: Placebo

Interventions

EDP-297 DRUG

EDP-297 Oral solution

EDP-297 MAD Cohorts; EDP-297 SAD Cohorts

Placebo DRUG

placebo to match EDP-297

EDP-297 MAD Placebo Cohort; EDP-297 SAD Placebo Cohort

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• PRA Health Sciences: collaborator

Study Sites (1)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36369848 DERIVED

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 22, 2020
• Study Start: September 8, 2020
• Primary Completion: June 21, 2021
• Study Completion: June 21, 2021
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

NL (1)