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intraconazole

Phase 1

NASH - Nonalcoholic Steatohepatitis | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Last Updated: Nov 6, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03213145Drug-drug Interaction Study Between EDP-305, Intraconazole and Rifampin in Healthy VolunteersPHASE1 COMPLETED 48Jul 11, 2017Sep 7, 2017Nov 6, 20171 United States
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Study Endpoints
Primary Endpoints
Cmax of EDP-305 with and without coadministration with itraconazole
Up to 19 days
AUC of EDP-305 with and without coadministration with itraconazole
Up to 19 days
Cmax of EDP-305 with and without coadministration with rifampin
Up to 17 days
AUC of EDP-305 with and without coadministration with rifampin
Up to 17 days
Secondary Endpoints
Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis).
Up to 19 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part 1EXPERIMENTAL -
Part 2EXPERIMENTAL -
Interventions
NameTypeDescription
intraconazoleDRUGSubjects will receive itraconazole once daily from Day 5 through Day18
RifampinDRUGSubjects will receive rifampin once daily from Day 5 through Day 16
EDP 305DRUGSubjects will receive EDP 305 once daily on Day 1 and Day 14
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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. * Female subjects must be of non-childbearing potential. Exclusion Criteria: * Clinically relevant evidence o...

Countries:United States
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