A Study of EDP-297 in Healthy Subjects

NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04559126
• Other study ID #: EDP 297-001
• Status: Completed
• Phase: Phase 1
• Start date: September 8, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: October 2021
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• NASH - Nonalcoholic Steatohepatitis With Liver Fibrosis
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• EDP-297
EDP-297 Oral solution
• Placebo
placebo to match EDP-297

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	PRA Health Sciences

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by adverse events		Up to 8 Days in SAD Cohorts
Primary	Safety measured by adverse events		Up to 21 Days in MAD Cohorts
Secondary	Cmax of EDP-297		Up to 6 Days in SAD Cohorts
Secondary	Cmax of EDP-297		Up to 18 Days in MAD Cohorts
Secondary	AUC of EDP-297		Up to 6 Days in SAD Cohorts
Secondary	AUC of EDP-297		Up to 18 Days in MAD Cohorts