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Caffeine

Phase 1

NASH | Small molecule | Metabolic |Enanta Pharmaceuticals, Inc.|Last Updated: Aug 21, 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
UNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03187496Drug-drug Interaction Study Between EDP-305, Midazolam, Caffeine and Rosuvastatin in Healthy Volunteers.PHASE1 COMPLETED 24 — — May 11, 2017Jun 14, 2017Aug 21, 20171 United States
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Study Endpoints
Primary Endpoints
Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.
Up to 17 Days
AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-305.
Up to 17 days
Secondary Endpoints
Cmax of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
Up to 17 days
AUC of 1'-hydroxymidazolam, paraxanthine and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
Up to 17 days
Tmax of midazolam, 1'-hydroxymidazolam, caffeine, paraxanthine, rosuvastatin and N-desmethyl-rosuvastatin with and without the coadministration of EDP-305.
Up to 17 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTAL -
Interventions
NameTypeDescription
MidazolamDRUGEach subject will receive midazolam on Days 1 and 12.
CaffeineDRUGEach subject will receive caffeine on Days 1 and 12.
RosuvastatinDRUGEach subject will receive rosuvastatin on Days 2 and 13.
EDP-305DRUGEach subject will receive EDP-305 on Days 5 through 15.
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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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