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EDP-788

Phase 1

Undisclosed | Small molecule | Other |Enanta Pharmaceuticals, Inc.|Trials Updated: Jan 9, 2015

EDP-788 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Dec 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

EDP-788 clinical trials

EDP-788 · 1 trial · 1 indication

Phase 1 1
NCT01999725Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788Safety in Normal Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788
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Study Endpoints

Primary Endpoints

Incidence and severity of adverse events
From time of dosing to 8 - 10 days after receiving study drug

Secondary Endpoints

Changes from baseline in laboratory values and vital signs
From time of dosing to 8 - 10 days after receiving study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EDP-788EXPERIMENTALSingle doses with dose escalation to continue in successive cohorts
PlaceboPLACEBO_COMPARATORSingle dose with matching placebo

Interventions

NameTypeDescription
EDP-788DRUGEDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
PlaceboDRUGMatching placebo capsules or matching suspension
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * In good general health * BMI between 18 - 32 kg/m2 * Women must be of non-childbearing potential (surgically sterilized) * Normal electrocardiogram * Willing to abstain from strenuous physical exercise starting 3 days prior to admission to the study clinic through the 8 - ...

Countries:United States
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Frequently asked questions about EDP-788

What is EDP-788?

EDP-788 is an investigational small molecule developed by Enanta Pharmaceuticals, Inc. (ticker ENTA). It has been studied in a Phase 1 clinical trial evaluating safety and pharmacokinetics in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing EDP-788?

EDP-788 is being developed by Enanta Pharmaceuticals, Inc., which trades under the ticker symbol ENTA. Enanta is the sponsor of the clinical program for this small molecule candidate.

What phase is EDP-788 in?

EDP-788 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA.

What clinical trials is EDP-788 in?

EDP-788 has been evaluated in one completed Phase 1 trial, NCT01999725, titled Evaluation of the Safety and Pharmacokinetics of a Single Oral Dose of EDP-788. The trial enrolled 80 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.

How was the EDP-788 Phase 1 trial designed?

The Phase 1 trial of EDP-788, NCT01999725, was a randomized, double-blind, placebo-controlled study of a single oral dose. It enrolled 80 healthy volunteers aged 18 years and older in the United States and assessed safety and pharmacokinetics. The trial has been completed.