A Study of EDP-297 in Healthy Subjects

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis

Treatments: Drug: EDP-297; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04559126

EDP 297-001

Details and patient eligibility

About

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.

Full 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

Enrollment: 82 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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82 participants in 4 patient groups, including a placebo group

EDP-297 SAD Cohorts

Experimental group

Description:

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

Treatment:

Drug: EDP-297

EDP-297 MAD Cohorts

Experimental group

Description:

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

Treatment:

Drug: EDP-297

EDP-297 SAD Placebo Cohort

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

EDP-297 MAD Placebo Cohort

Placebo Comparator group

Description:

Matching placebo, oral solution, once daily for 14 days

Treatment:

Drug: Placebo