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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04559126
Other study ID # EDP 297-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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