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Open-label TRV734

Phase 1

Healthy | Small molecule | Other |Trevena, Inc.|Last Updated: Nov 18, 2015

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
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment93
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02411500A Pharmacokinetic, Safety and Tolerability Study in Healthy Adult MalesPHASE1 COMPLETED 18 — — Feb 1, 2015Mar 1, 2015Nov 18, 20151 United States
NCT02211625A Safety, Tolerability, PD and PK Study in Healthy AdultsPHASE1 COMPLETED 75 — — Jul 1, 2014Oct 1, 2014Dec 5, 20141 United States
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Study Endpoints
Primary Endpoints
Evaluate the maximum observed plasma concentration (Cmax)
9-days
Evaluate the time at which the maximum plasma concentration was observed (tmax)
9-days
Evaluate the area under the plasma concentration-time curve from time 0 to the last measurable plasma concentration (AUC0-t)
9-days
Evaluate the area under the plasma concentration-time curve from time 0 to time extrapolated to infinity (AUC0-inf)
9-days
Evaluate the apparent elimination half-life (t1/2)
9-days
Evaluate the apparent clearance (CL/F)
9-days
Safety
7 days

Clinical safety data from adverse event reporting, clinical observations, 12-lead ECGs, cardiac telemetry monitoring, vital signs (blood pressure, heart rate, respiratory rate and oral temperature), oxygen saturation and safety laboratory tests.

Secondary Endpoints
Safety and tolerability as measured by adverse events
9-days
Safety and tolerability as measured by clinical observations
9-days
Safety and tolerability as measured by 12-lead ECGs
9-days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Formulation AEXPERIMENTAL -
Formulation BEXPERIMENTAL -
Formulation CEXPERIMENTAL -
Formulation DEXPERIMENTAL -
Formulation EEXPERIMENTAL -
Formulation FEXPERIMENTAL -
TRV734 125 mgEXPERIMENTALPart A, open-label will evaluate the the safety, PK and PD profile of a 125mg dose of TRV734 in which subjects are fasted, fed a standard meal, or fed a high-fat meal. Part A will also inform the dosing paradigm for Part B.
Multiple ascending dose study, active and placebo comparatorsACTIVE_COMPARATORPart B will assess the safety, tolerability, PD and PK of TRV734. Subjects will be randomized in a ratio of 3:1:1 to receive either multiple doses of TRV734, oxycodone IR 10mg or placebo.
Interventions
NameTypeDescription
TRV734DRUGSubjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
Open-label TRV734 125 mgDRUG125 mg
TRV734 blindedDRUGblinded, multiple ascending dose
Oxycodone IR 10 mgDRUG -
PlaceboDRUGTRV734-matched and oxycodone placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician or trained qualified designee * Males: 18 - 55 years inclusive at screening * Capable of giving written informed consent Exclusion Criteria: * Clinically significant conditions or history of fainting or syncope * Medical or ps...

Countries:United States
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