Recent Updates
Recently added Catalysts

Radiolabeled TRV130

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
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02169934A Study to Investigate the Metabolism and Excretion of [14C]-TRV130 in Healthy Male SubjectsPHASE1 COMPLETED 6 — — Jun 1, 2014May 1, 2015Nov 18, 20151 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To assess the pharmacokinetics (PK) of a single IV dose of [14C]-TRV130
Day 1 - Day 13
To determine plasma concentrations of total radioactivity
Day 1 - Day 13
To determine whole blood concentrations of total radioactivity
Day 1 - Day 13
To determine urine concentrations of total radioactivity
Day 1 - Day 13
To determine fecal concentration of total radioactivity
Day 1 - Day 13
Secondary Endpoints
To identify metabolites associated with TRV130 in blood, urine and feces
Day 1 - Day 13
Number of patients experiencing an Adverse Event
Day 1 - Day 13
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Radiolabeled TRV130EXPERIMENTAL -
Interventions
NameTypeDescription
Radiolabeled TRV130DRUGA single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 64 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Males, between 18 and 64 years of age, inclusive * With body weight ≥ 50 kg and body mass index (BMI) between 18 and 32 kg/m2, inclusive * In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs * Negative test fo...

Countries:United States
Unlock Eligibility Criteria