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TRV130A

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment74

FDA Designations

No designations recorded

Clinical trial landscape

TRV130A · 1 trial · 1 indication

Phase 1 1
NCT01514578Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult MalesHealthy
COMPLETED74 Analytics
PHASE1COMPLETED
Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about TRV130A

What is TRV130A used for?

TRV130A is an investigational small molecule being studied in healthy volunteers. It is being developed by Trevena, Inc. for potential therapeutic use, though its specific target indication has not been established. The drug is currently in early-stage clinical development.

Who makes TRV130A?

TRV130A is being developed by Trevena, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol TRVN. The company is conducting clinical research on this investigational small molecule.

What phase is TRV130A in?

TRV130A is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied in healthy volunteers to assess its safety and tolerability.

What clinical trials is TRV130A in?

TRV130A has one completed Phase 1 clinical trial, identified as NCT01514578. This was a single ascending dose study of intravenous TRV130A in healthy adult males, conducted in the United States with 74 participants.

Is TRV130A the same as oliceridine?

TRV130A is an investigational drug being developed by Trevena, Inc. It is a small molecule that has been studied in healthy volunteers. No alternative names for this drug have been disclosed in the available clinical trial information.