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TRV130A

Phase 1

Healthy | Small molecule | Other |Trevena, Inc.|Last Updated: Aug 24, 2012

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
RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment74
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01514578Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult MalesPHASE1 COMPLETED 74Jan 1, 2012Jul 1, 2012Aug 24, 20121 United States
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Study Endpoints
Primary Endpoints
Number of subjects with adverse events
Baseline to 8 days after dose administration
Area under the plasma concentration versus time curve of TRV130A
Baseline to 24 hours after dose administration
Secondary Endpoints
Effect of TRV130A on pain perception using cold pain test
Baseline to 3 hours after dose administration
Effect of TRV130A on pupil diameter
Baseline to 3 hours after dose administration
Effect of TRV130A on eye movements
Baseline to 3 hours after dose administration
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TRV130AEXPERIMENTAL -
Dextrose in WaterPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
TRV130ADRUGIntravenous infusion of 1 hour duration
Dextrose in WaterDRUGIntravenous infusion of 1 hour duration
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Eligibility Criteria
Age Range19 Years — 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult male 19 - 50 years of age * Body weight \>/= 50 kg * Capable of giving written informed consent Exclusion Criteria: * Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfe...

Countries:United States
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