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Orvepitant

Phase 1

Depressive Disorder | Small molecule | Other |GSK plc|Last Updated: Jul 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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00843011Food and Relative Bioavailability StudyPHASE1 COMPLETED 14Aug 28, 2008Oct 23, 2008Jul 21, 20171 Italy
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Study Endpoints
Primary Endpoints
Pharmacokinetic:parameters of orvepitant: tlag, tmax, Cmax, AUC(0-t), AUC (0-∞), t1/2.
72 hours post dose.
Safety and tolerability endpoints will be evaluated by adverse event monitoring,laboratory values, cardiovascular monitoring
5 weeks.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALOrvepitant 60 mg
Interventions
NameTypeDescription
OrvepitantDRUGOrvepitant 60 mg, single dose. 2 different formulation. Formulation 2 is administered with and without food.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female between 18 and 65 years of age inclusive. * A female subject is eligible to participate if she is of either non-childbearing potential or child-bearing potential and agrees to use one of the contraception methods * No co-morbid Psychiatric Disorders as d...

Countries:Italy
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