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A Study of EDP-938 in Healthy Subjects

Primary Purpose

RSV Infection

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EDP-938

Placebo

About this trial

This is an interventional treatment trial for RSV Infection focused on measuring First-in-Human, Single Ascending Dose, Multiple Ascending Dose

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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 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.

Sites / Locations

Pharmaceutical Research Associates, Inc.,

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

EDP-938 SAD Cohorts

EDP-938 MAD Cohorts

EDP-938 SAD Placebo Cohort

EDP-938 MAD Placebo Cohort

Arm Description

EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration

EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days

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

Matching placebo, oral suspension, once daily for 7 days

Outcomes

Primary Outcome Measures

Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).

Secondary Outcome Measures

Cmax of EDP-938

AUC of EDP-938

Full Information

NCT ID

NCT03384823

First Posted

December 20, 2017

Last Updated

October 9, 2018

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

1. Study Identification

Unique Protocol Identification Number

NCT03384823

Brief Title

A Study of EDP-938 in Healthy Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Completed

Study Start Date

December 7, 2017 (Actual)

Primary Completion Date

July 3, 2018 (Actual)

Study Completion Date

July 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

RSV Infection

Keywords

First-in-Human, Single Ascending Dose, Multiple Ascending Dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

90 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EDP-938 SAD Cohorts

Arm Type

Experimental

Arm Description

EDP-938 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, and Dose 6 oral suspension, once daily in one single administration

Arm Title

EDP-938 MAD Cohorts

Arm Type

Experimental

Arm Description

EDP-938 Dose 1, Dose 2, Dose 3, and Dose 4 oral suspension, once daily for 7 days

Arm Title

EDP-938 SAD Placebo Cohort

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

EDP-938 MAD Placebo Cohort

Arm Type

Placebo Comparator

Arm Description

Matching placebo, oral suspension, once daily for 7 days

Intervention Type

Drug

Intervention Name(s)

EDP-938

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo to match EDP-938

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Cmax of EDP-938

Time Frame

Up to 5 Days

Title

Cmax of EDP-938

Time Frame

Up to 11 Days

Title

AUC of EDP-938

Time Frame

Up to 5 Days

Title

AUC of EDP-938

Time Frame

Up to 11 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Enanta Pharmaceuticals, Inc

Organizational Affiliation

Enanta Pharmaceuticals, Inc

Official's Role

Study Director

Facility Information:

Facility Name

Pharmaceutical Research Associates, Inc.,

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

12. IPD Sharing Statement

Learn more about this trial

A Study of EDP-938 in Healthy Subjects

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