A Study of EDP-938 in Healthy Subjects

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03384823

Collaborator

Pharmaceutical Research Associates (Other)

Enrollment

Location

Arms

6.8

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
RSV Infection	Drug: EDP-938 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Dec 7, 2017

Actual Primary Completion Date :

Jul 3, 2018

Actual Study Completion Date :

Jul 3, 2018

Arms and Interventions

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

Outcome Measures

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). [Up to 8 days]

Secondary Outcome Measures

Cmax of EDP-938 [Up to 5 Days]
Cmax of EDP-938 [Up to 11 Days]
AUC of EDP-938 [Up to 5 Days]
AUC of EDP-938 [Up to 11 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pharmaceutical Research Associates, Inc.,	Lenexa	Kansas	United States	66219

Sponsors and Collaborators

Enanta Pharmaceuticals
Pharmaceutical Research Associates

Investigators

Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Enanta Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03384823

Other Study ID Numbers:

EDP-938-001

First Posted:

Dec 27, 2017

Last Update Posted:

Oct 10, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Enanta Pharmaceuticals

First-in-Human

Single Ascending Dose

Multiple Ascending Dose

Additional relevant MeSH terms:

Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Oct 10, 2018