Status:
COMPLETED
A Study of EDP-938 in Healthy Subjects
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
Pharmaceutical Research Associates
Conditions:
RSV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2018
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03384823
Start Date
December 7 2017
End Date
July 3 2018
Last Update
October 10 2018
Active Locations (1)
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1
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States, 66219