A Study of EDP-938 in Healthy Subjects

NCT03384823 | Completed Phase 1 FDA Drug

• 1 other identifier: EDP-938-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

RSV Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (4)

EDP-938 SAD Cohorts

EXPERIMENTAL

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

EDP-938 MAD Cohorts

EXPERIMENTAL

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

Drug: EDP-938

EDP-938 SAD Placebo Cohort

PLACEBO COMPARATOR

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

Drug: Placebo

EDP-938 MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, oral suspension, once daily for 7 days

Drug: Placebo

Interventions

EDP-938 DRUG

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).

EDP-938 MAD Cohorts; EDP-938 SAD Cohorts

Placebo DRUG

placebo to match EDP-938

EDP-938 MAD Placebo Cohort; EDP-938 SAD Placebo Cohort

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead
• Pharmaceutical Research Associates: collaborator

Study Sites (1)

Pharmaceutical Research Associates, Inc.,

Lenexa, Kansas, 66219, United States

Location

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Interventions

EDP-938

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: December 27, 2017
• Study Start: December 7, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: October 10, 2018

Record last verified: 2018-10

Locations

US (1)