A Study of EDP-938 in Healthy Subjects

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: RSV Infection

Treatments: Drug: EDP-938; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03384823

EDP-938-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 4 patient groups, including a placebo group

EDP-938 SAD Cohorts

Experimental group

Description:

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

Treatment:

Drug: EDP-938

EDP-938 MAD Cohorts

Experimental group

Description:

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

Treatment:

Drug: EDP-938

EDP-938 SAD Placebo Cohort

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

EDP-938 MAD Placebo Cohort

Placebo Comparator group

Description:

Matching placebo, oral suspension, once daily for 7 days

Treatment:

Drug: Placebo