A Study of EDP-938 in Healthy Subjects

October 9, 2018 updated by: Enanta Pharmaceuticals, Inc

A Randomized, Double-Blind, Placebo-Controlled, First-In-Human Study of Orally Administered EDP-938 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD), Multiple Ascending Doses (MAD) and the Effect of Food on EDP-938 Pharmacokinetics in Healthy Subjects

This randomized, double-blind, placebo-controlled study will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-938 in healthy adult subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first phase assesses single ascending doses for EDP-938 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect.

The second phase assesses multiple ascending doses (active drug or placebo) for 7-days in healthy subjects.

Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-938 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-938 or placebo.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Pharmaceutical Research Associates, Inc.,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 55 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 -1.
  • Current tobacco smokers or use of tobacco within 3 months prior to screening.
  • Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
  • History of regular alcohol consumption.
  • Participation in a clinical trial within 30 days prior to the first dose of study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EDP-938 SAD Cohorts
EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration
Drug: EDP-938
Subjects will receive either a single dose of EDP-938 on Day 1 only (SAD) or a single dose of EDP-938 starting on Day 1 through Day 7 (MAD).
EXPERIMENTAL: EDP-938 MAD Cohorts
EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days
Drug: EDP-938
Subjects will receive either a single dose of EDP-938 on Day 1 only (SAD) or a single dose of EDP-938 starting on Day 1 through Day 7 (MAD).
PLACEBO_COMPARATOR: EDP-938 SAD Placebo Cohort
Matching placebo, oral suspension, once daily in one single administration
Drug: Placebo
placebo to match EDP-938
PLACEBO_COMPARATOR: EDP-938 MAD Placebo Cohort
Matching placebo, oral suspension, once daily for 7 days
Drug: Placebo
placebo to match EDP-938

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Time Frame: Up to 8 days
Up to 8 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax of EDP-938
Time Frame: Up to 5 Days
Up to 5 Days
Cmax of EDP-938
Time Frame: Up to 11 Days
Up to 11 Days
AUC of EDP-938
Time Frame: Up to 5 Days
Up to 5 Days
AUC of EDP-938
Time Frame: Up to 11 Days
Up to 11 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 7, 2017

Primary Completion (ACTUAL)

July 3, 2018

Study Completion (ACTUAL)

July 3, 2018

Study Registration Dates

First Submitted

December 20, 2017

First Submitted That Met QC Criteria

December 20, 2017

First Posted (ACTUAL)

December 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 10, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP-938-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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