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TRV130A

Phase 1

Undisclosed | Small molecule | Other |Trevena, Inc.|Trials Updated: Aug 24, 2012

TRV130A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 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

TRV130A clinical trials

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
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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 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?

TRV130A is an investigational small molecule developed by Trevena, Inc. It has been studied in a Phase 1 clinical trial involving healthy adult male volunteers. The specific therapeutic indications for TRV130A have not been disclosed, and the compound remains in early-stage clinical development.

Who is developing TRV130A?

TRV130A is being developed by Trevena, Inc., which trades under the ticker symbol TRVN. The company sponsored the Phase 1 clinical study of the compound. Trevena is the developer associated with TRV130A in its clinical program.

What phase is TRV130A in?

TRV130A is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.

What clinical trials is TRV130A in?

TRV130A has been evaluated in one completed Phase 1 trial, NCT01514578, titled Single Ascending Dose Study of Intravenous TRV130A in Healthy Adult Males. The trial enrolled 74 participants in the United States and was randomized and placebo-controlled, though not double-blind.

What was the design of the TRV130A Phase 1 trial?

The Phase 1 trial NCT01514578 was a single ascending dose study of intravenous TRV130A in healthy adult males. It enrolled 74 participants, was randomized and placebo-controlled, and was conducted in the United States. The study has been completed.